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| Model Number 479201 |
| Device Problem
Signal Artifact/Noise (1036)
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| Patient Problem
No Patient Involvement (2645)
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| Event Date 10/13/2016 |
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Event Type
malfunction
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Manufacturer Narrative
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No hospital/medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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Event Description
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It was reported that after a breast wire localization procedure on a phantom patient and tissue, the wire allegedly produced an artifact that was visible under mr imaging and affected the reading of the image.Reportedly, the procedure was completed with the same device.There was no patient contact.
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Manufacturer Narrative
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Manufacturing review: a manufacturing review was conducted.The lot met all release criteria.Visual/microscopic inspection: the original device and two lot samples were returned.Opened sample: two cannulas were returned with one wire.The wire and cannulas appeared to be clean; however, a fibrous material was found at the barb of the wire.Per the reported event details, the device was used in a phantom patient.It is possible that the fibrous material came from the phantom patient.The wire was returned deployed.The wire was bent approximately 4.0" from the twisted tip.No other anomalies were found on the wire or cannulas.Lot sample #1: sealed lot sample.The wire appeared clean.The wire was received inside the cannula.The wire was able to be deployed without issue.No anomalies noted to the wire.No anomalies noted to the cannula.Lot sample #2: sealed lot sample.The wire appeared clean.The wire was received inside the cannula.The wire was able to be deployed without issue.No anomalies noted to the wire.No anomalies noted to the cannula.Functional/performance evaluation: a functional/performance evaluation was not performed as it is not applicable to the reported event.A material analysis was performed.All three wires showed a similar eds spectrum, which indicated major chromium (cr), nickel (ni) and molybdenum (mo) peaks with a minor niobium (nb) peak.One of the needles from the opened sample and the two needles from the two lot samples showed consistent eds spectra.The spectra were similar to the wires with a small addition of iron (fe).The spectrum for the second needle from the opened sample showed an eds spectrum consistent with a 300 series stainless steel.A manufacturing review of the raw material used was performed and identified 5 additional lots were manufactured with the same raw material.One similar event was identified within these 5 lots manufactured from the same raw material.A certificate of conformance was provided by the supplier, for the raw materials used to manufacture lot rezl0066.Furthermore, the material certifications from the sub-supplier, were also provided.The certifications all met specification.A sales review was performed for the facility and it was noted that in the past 26 months (november 2014 - december 2016) the facility has purchased both mri and non-mri ghiatas localization needles (catalog #'s: 47720, 479201, and 47920).Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: one original sample was returned opened with one ghiatas localization wire and two ghiatas coaxial cannulas inside.Additionally, two ghiatas lot samples were returned for evaluation.Images were not returned.Materials analysis was performed on all of the devices returned.One of the cannulas returned with the opened sample was found to be consistent with stainless steel.However, it is unknown why two cannulas were returned inside of the opened package.The remaining devices were all found to be of the appropriate alloy.Therefore, the investigation is inconclusive for the reported artifact, as the reported conditions of use could not be recreated (patient imaged with the device under mri) and the origin of the second cannula provided with the opened sample is unknown.Per the evaluation results, one cannula received within the opened packaging was found to be of a material consistent with stainless steel.However, it could not be determined if both cannulas were from the same catalog/lot number.A sales review indicated that the facility has purchased both mri and non-mri ghiatas needles.Therefore, based on the available information, the definitive root cause could not be determined.Labeling review: the current ghiatas breast localization wire instructions for use (ifu) states: general information and device description: the ghiatas® beaded breast localization wire consists of an introducer needle and a semi-rigid localization wire.The introducer needle is comprised of a plastic molded hub, 1cm depth reference marks, and an ultrasound enhancement on the distal end to aid in needle placement.*the semi-rigid localization wire has 1cm marking beads at the distal end of the wire and a palpable deployment bead to signify the point at which the barb at the distal end of the wire will be deployed.Product codes 49520, 49720 and 49920 have longer beads at the distal end of the wire which add a stiffening effect to the wire.Indications for use: this device is intended for use during breast lesion surgery as a guide for the surgeon to follow in the excision of the lesion.Precautions: this device should only be used by a physician trained in its indicated use, limitations, and possible complications of percutaneous needle techniques.The introduction of the device into the body should be carried out under imaging control.Before using, inspect the device for damage that would prevent proper function.If the components are damaged or bent, do not use.This device is mr conditional: the following codes can be can be placed and imaged under mr: 470201, 475201, 477201, 479201.Non-clinical testing has demonstrated that the mr ghiatas® localization wire is mr conditional.It can be scanned safely under the following conditions: static magnetic field of 3-tesla or less spatial gradient field of 720-gauss/cm or less in non-clinical testing, the mr ghiatas® localization wire product codes produced a temperature rise of less than +0.9°c at a maximum mr system reported whole body averaged specific body absorption rate (sar) of 3-w/kg of 15-minutes of mr scanning in a 3-tesla, signa mr system (excite platform; g3.0-052b software, ge healthcare, milwaukee, wi).Mr image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the mr ghiatas® localization wire.Therefore, it may be necessary to optimize mr imaging parameters for the presence of this metallic implant.(b)(4).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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Event Description
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It was reported that after a breast wire localization procedure on a phantom patient and tissue, the wire allegedly produced an artifact that was visible under mr imaging and affected the reading of the image.Reportedly, the procedure was completed with the same device.There was no patient contact.
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Manufacturer Narrative
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The affected product catalog number, lot number and failure mode combination has been classified by the fda as a class ii recall, z-1900-2017.Manufacturing review: a manufacturing review was conducted.The lot met all release criteria.Visual/microscopic inspection: the original device and two lot samples were returned.Opened sample: two cannulas were returned with one wire.The wire and cannulas appeared to be clean; however, a fibrous material was found at the barb of the wire.Per the reported event details, the device was used in a phantom patient.It is possible that the fibrous material came from the phantom patient.The wire was returned deployed.The wire was bent approximately 4.0" from the twisted tip.No other anomalies were found on the wire or cannulas.Lot sample #1: sealed lot sample.The wire appeared clean.The wire was received inside the cannula.The wire was able to be deployed without issue.No anomalies noted to the wire.No anomalies noted to the cannula.Lot sample #2: sealed lot sample.The wire appeared clean.The wire was received inside the cannula.The wire was able to be deployed without issue.No anomalies noted to the wire.No anomalies noted to the cannula.Functional/performance evaluation: a functional/performance evaluation was not performed as it is not applicable to the reported event.A material analysis was performed.All three wires showed a similar eds spectrum, which indicated major chromium (cr), nickel (ni) and molybdenum (mo) peaks with a minor niobium (nb) peak.One of the needles from the opened sample and the two needles from the two lot samples showed consistent eds spectra.The spectra were similar to the wires with a small addition of iron (fe).The spectrum for the second needle from the opened sample showed an eds spectrum consistent with a 300 series stainless steel.A manufacturing review of the raw material used was performed and identified 5 additional lots were manufactured with the same raw material.One similar event was identified within these 5 lots manufactured from the same raw material.A certificate of conformance was provided by the supplier, for the raw materials used to manufacture lot rezl0066.Furthermore, the material certifications from the sub-supplier, were also provided.The certifications all met specification.A sales review was performed for the facility and it was noted that in the past 26 months (november 2014 - december 2016) the facility has purchased both mri and non-mri ghiatas localization needles (catalog #'s: 47720, 479201, and 47920).Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: one original sample was returned opened with one ghiatas localization wire and two ghiatas coaxial cannulas inside.Additionally, two ghiatas lot samples were returned for evaluation.Images were not returned.Materials analysis was performed on all of the devices returned.One of the cannulas returned with the opened sample was found to be consistent with stainless steel.However, it is unknown why two cannulas were returned inside of the opened package.The remaining devices were all found to be of the appropriate alloy.Therefore, the investigation is inconclusive for the reported artifact, as the reported conditions of use could not be recreated (patient imaged with the device under mri) and the origin of the second cannula provided with the opened sample is unknown.Per the evaluation results, one cannula received within the opened packaging was found to be of a material consistent with stainless steel.However, it could not be determined if both cannulas were from the same catalog/lot number.A sales review indicated that the facility has purchased both mri and non-mri ghiatas needles.Therefore, based on the available information, the definitive root cause could not be determined.Labeling review: the current ghiatas breast localization wire instructions for use (ifu) states: general information and device description: the ghiatas® beaded breast localization wire consists of an introducer needle and a semi-rigid localization wire.The introducer needle is comprised of a plastic molded hub, 1cm depth reference marks, and an ultrasound enhancement on the distal end to aid in needle placement.*the semi-rigid localization wire has 1cm marking beads at the distal end of the wire and a palpable deployment bead to signify the point at which the barb at the distal end of the wire will be deployed.Product codes 49520, 49720 and 49920 have longer beads at the distal end of the wire which add a stiffening effect to the wire.Indications for use: this device is intended for use during breast lesion surgery as a guide for the surgeon to follow in the excision of the lesion.Precautions: 1.This device should only be used by a physician trained in its indicated use, limitations, and possible complications of percutaneous needle techniques.2.The introduction of the device into the body should be carried out under imaging control.3.Before using, inspect the device for damage that would prevent proper function.If the components are damaged or bent, do not use.This device is mr conditional: the following codes can be can be placed and imaged under mr: (b)(4).Non-clinical testing has demonstrated that the mr ghiatas® localization wire is mr conditional.It can be scanned safely under the following conditions: static magnetic field of 3-tesla or less spatial gradient field of 720-gauss/cm or less in non-clinical testing, the mr ghiatas® localization wire product codes produced a temperature rise of less than +0.9°c at a maximum mr system reported whole body averaged specific body absorption rate (sar) of 3-w/kg of 15-minutes of mr scanning in a 3-tesla, signa mr system (excite platform; g3.0-052b software, ge healthcare, milwaukee, wi).Mr image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the mr ghiatas® localization wire.Therefore, it may be necessary to optimize mr imaging parameters for the presence of this metallic implant.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
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Event Description
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It was reported that after a breast wire localization procedure on a phantom patient and tissue, the wire allegedly produced an artifact that was visible under mr imaging and affected the reading of the image.Reportedly, the procedure was completed with the same device.There was no patient contact.
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Manufacturer Narrative
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The previously submitted emdr inaccurately reported the date.The date should have been reported as (b)(6) 2017.The affected product catalog number, lot number and failure mode combination has been classified by the fda as a class ii recall, z-1900-2017.Manufacturing review: a manufacturing review was conducted.The lot met all release criteria.Visual/microscopic inspection: the original device and two lot samples were returned.Opened sample: two cannulas were returned with one wire.The wire and cannulas appeared to be clean; however, a fibrous material was found at the barb of the wire.Per the reported event details, the device was used in a phantom patient.It is possible that the fibrous material came from the phantom patient.The wire was returned deployed.The wire was bent approximately 4.0" from the twisted tip.No other anomalies were found on the wire or cannulas.Lot sample #1: sealed lot sample.The wire appeared clean.The wire was received inside the cannula.The wire was able to be deployed without issue.No anomalies noted to the wire.No anomalies noted to the cannula.Lot sample #2: sealed lot sample.The wire appeared clean.The wire was received inside the cannula.The wire was able to be deployed without issue.No anomalies noted to the wire.No anomalies noted to the cannula.Functional/performance evaluation: a functional/performance evaluation was not performed as it is not applicable to the reported event.A material analysis was performed.All three wires showed a similar eds spectrum, which indicated major chromium (cr), nickel (ni) and molybdenum (mo) peaks with a minor niobium (nb) peak.One of the needles from the opened sample and the two needles from the two lot samples showed consistent eds spectra.The spectra were similar to the wires with a small addition of iron (fe).The spectrum for the second needle from the opened sample showed an eds spectrum consistent with a 300 series stainless steel.A manufacturing review of the raw material used was performed and identified 5 additional lots were manufactured with the same raw material.One similar event was identified within these 5 lots manufactured from the same raw material.A certificate of conformance was provided by the supplier, for the raw materials used to manufacture lot rezl0066.Furthermore, the material certifications from the sub-supplier, were also provided.The certifications all met specification.A sales review was performed for the facility and it was noted that in the past 26 months (november 2014 - december 2016) the facility has purchased both mri and non-mri ghiatas localization needles (catalog #'s: 47720, 479201, and 47920).Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: one original sample was returned opened with one ghiatas localization wire and two ghiatas coaxial cannulas inside.Additionally, two ghiatas lot samples were returned for evaluation.Images were not returned.Materials analysis was performed on all of the devices returned.One of the cannulas returned with the opened sample was found to be consistent with stainless steel.However, it is unknown why two cannulas were returned inside of the opened package.The remaining devices were all found to be of the appropriate alloy.Therefore, the investigation is inconclusive for the reported artifact, as the reported conditions of use could not be recreated (patient imaged with the device under mri) and the origin of the second cannula provided with the opened sample is unknown.Per the evaluation results, one cannula received within the opened packaging was found to be of a material consistent with stainless steel.However, it could not be determined if both cannulas were from the same catalog/lot number.A sales review indicated that the facility has purchased both mri and non-mri ghiatas needles.Therefore, based on the available information, the definitive root cause could not be determined.Labeling review: the current ghiatas breast localization wire instructions for use (ifu) states: general information and device description: the ghiatas® beaded breast localization wire consists of an introducer needle and a semi-rigid localization wire.The introducer needle is comprised of a plastic molded hub, 1cm depth reference marks, and an ultrasound enhancement on the distal end to aid in needle placement.*the semi-rigid localization wire has 1cm marking beads at the distal end of the wire and a palpable deployment bead to signify the point at which the barb at the distal end of the wire will be deployed.Product codes 49520, 49720 and 49920 have longer beads at the distal end of the wire which add a stiffening effect to the wire.Indications for use: this device is intended for use during breast lesion surgery as a guide for the surgeon to follow in the excision of the lesion.Precautions: 1.This device should only be used by a physician trained in its indicated use, limitations, and possible complications of percutaneous needle techniques.2.The introduction of the device into the body should be carried out under imaging control.3.Before using, inspect the device for damage that would prevent proper function.If the components are damaged or bent, do not use.This device is mr conditional: the following codes can be can be placed and imaged under mr: 470201 475201 477201 479201 non-clinical testing has demonstrated that the mr ghiatas® localization wire is mr conditional.It can be scanned safely under the following conditions: static magnetic field of 3-tesla or less spatial gradient field of 720-gauss/cm or less in non-clinical testing, the mr ghiatas® localization wire product codes produced a temperature rise of less than +0.9°c at a maximum mr system reported whole body averaged specific body absorption rate (sar) of 3-w/kg of 15-minutes of mr scanning in a 3-tesla, signa mr system (excite platform; g3.0-052b software, ge healthcare, milwaukee, wi).Mr image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the mr ghiatas® localization wire.Therefore, it may be necessary to optimize mr imaging parameters for the presence of this metallic implant.
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Event Description
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It was reported that after a breast wire localization procedure on a phantom patient and tissue, the wire allegedly produced an artifact that was visible under mr imaging and affected the reading of the image.Reportedly, the procedure was completed with the same device.There was no patient contact.
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Search Alerts/Recalls
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