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BARD PERIPHERAL VASCULAR, INC. GHIATAS LOCALIZATION WIRE BIOPSY INSTRUMENT; BREAST LOCALIZATION WIRE
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Back to Search Results |
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| Model Number 477201 |
| Device Problems
Signal Artifact/Noise (1036); Device Markings/Labelling Problem (2911)
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| Patient Problem
No Consequences Or Impact To Patient (2199)
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| Event Date 11/07/2016 |
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Event Type
malfunction
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Manufacturer Narrative
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No medical records and no medical images were provided to the manufacturer.The lot number of the device was provided.The device history records are currently under review.The return of the device is pending.The investigation 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 during a breast localization wire placement, the device allegedly created an artifact under mri imaging.It was further reported that the procedure was completed with another wire.There was no reported patient injury.
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Manufacturer Narrative
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Manufacturing review: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual/microscopic inspection: opened sample #1: the cannula was not returned with the wire.The wire was returned deployed.The wire was bent.The barb was also bent.A fibrous material was noted on the wire.The fibrous material and the bends will be considered incidental findings as they were not reported by the user.No other anomalies were noted.Opened sample #2: the cannula was not returned with the wire.The wire was returned deployed.The wire was bent.The bend will be considered an incidental finding as it was not reported by the user.No other anomalies were noted.Opened sample #3: the cannula was not returned with the wire.The wire was returned deployed.The wire was bent approximately 3.75" from the proximal end.The barb was also bent.The bends will be considered incidental findings as they were not reported by the user.No other anomalies were noted.Lot samples #1 - #7: the lot samples were returned sealed.The samples were returned with protective tubing.The blue wire clips were also returned.No anomalies were noted.Functional/performance evaluation: opened samples #1 - #3: functional testing could not be performed as the cannulas were not returned with the wires.Lot samples #1 - #7: the wires were received inside the cannulas.The wires were able to be deployed without issue.Medical records review: medical records were not provided; therefore, a medical records review could not be performed.Image/photo review: based on the images provided, no blooming artifact was demonstrated prior to the introduction of the localization wire, can be confirmed.Based on the images provided, blooming artifact was demonstrated at the location of the localization wire, can be confirmed.Based on the images provided, cardiac motion artifact was demonstrated; however, the cardiac motion artifact did not disrupt the localization wire procedure, can be confirmed.Conclusion: based, on the images provided, the investigation is confirmed for the reported artifact.Additionally, the investigation is confirmed for a device markings issue.An investigation is currently underway for a potential mixed material issue.Labeling review: the current ifu (instructions for use) 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.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 during a breast localization wire placement, the device allegedly created an artifact under mri imaging.It was further reported that the procedure was completed with another wire.There was no reported patient injury.
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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: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual/microscopic inspection: opened sample #1: the cannula was not returned with the wire.The wire was returned deployed.The wire was bent.The barb was also bent.A fibrous material was noted on the wire.The fibrous material and the bends will be considered incidental findings as they were not reported by the user.No other anomalies were noted.Opened sample #2: the cannula was not returned with the wire.The wire was returned deployed.The wire was bent.The bend will be considered an incidental finding as it was not reported by the user.No other anomalies were noted.Opened sample #3: the cannula was not returned with the wire.The wire was returned deployed.The wire was bent approximately 3.75" from the proximal end.The barb was also bent.The bends will be considered incidental findings as they were not reported by the user.No other anomalies were noted.Lot samples #1 - #7: the lot samples were returned sealed.The samples were returned with protective tubing.The blue wire clips were also returned.No anomalies were noted.Functional/performance evaluation: opened samples #1 - #3: functional testing could not be performed as the cannulas were not returned with the wires.Lot samples #1 - #7: the wires were received inside the cannulas.The wires were able to be deployed without issue.Medical records review: medical records were not provided; therefore, a medical records review could not be performed.Image/photo review: based on the images provided, no blooming artifact was demonstrated prior to the introduction of the localization wire, can be confirmed.Based on the images provided, blooming artifact was demonstrated at the location of the localization wire, can be confirmed.Based on the images provided, cardiac motion artifact was demonstrated; however, the cardiac motion artifact did not disrupt the localization wire procedure, can be confirmed.Conclusion: based, on the images provided, the investigation is confirmed for the reported artifact.Additionally, the investigation is confirmed for a device markings issue.An investigation is currently underway for a potential mixed material issue.Labeling review: the current ifu (instructions for use) 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,(b)(6), 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 during a breast localization wire placement, the device allegedly created an artifact under mri imaging.It was further reported that the procedure was completed with another wire.There was no reported patient injury.
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| |
|
Manufacturer Narrative
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The previously submitted emdr inaccurately reported the g4 date.The g4 date should have been reported as 05/23/2017.H10: 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: the device history records were reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Visual/microscopic inspection: opened sample #1: the cannula was not returned with the wire.The wire was returned deployed.The wire was bent.The barb was also bent.A fibrous material was noted on the wire.The fibrous material and the bends will be considered incidental findings as they were not reported by the user.No other anomalies were noted.Opened sample #2: the cannula was not returned with the wire.The wire was returned deployed.The wire was bent.The bend will be considered an incidental finding as it was not reported by the user.No other anomalies were noted.Opened sample #3: the cannula was not returned with the wire.The wire was returned deployed.The wire was bent approximately 3.75" from the proximal end.The barb was also bent.The bends will be considered incidental findings as they were not reported by the user.No other anomalies were noted.Lot samples #1 - #7: the lot samples were returned sealed.The samples were returned with protective tubing.The blue wire clips were also returned.No anomalies were noted.Functional/performance evaluation: opened samples #1 - #3: functional testing could not be performed as the cannulas were not returned with the wires.Lot samples #1 - #7: the wires were received inside the cannulas.The wires were able to be deployed without issue.Medical records review: medical records were not provided; therefore, a medical records review could not be performed.Image/photo review: based on the images provided, no blooming artifact was demonstrated prior to the introduction of the localization wire, can be confirmed.Based on the images provided, blooming artifact was demonstrated at the location of the localization wire, can be confirmed.Based on the images provided, cardiac motion artifact was demonstrated; however, the cardiac motion artifact did not disrupt the localization wire procedure, can be confirmed.Conclusion: based, on the images provided, the investigation is confirmed for the reported artifact.Additionally, the investigation is confirmed for a device markings issue.Labeling review: the current ifu (instructions for use) 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 during a breast localization wire placement, the device allegedly created an artifact under mri imaging.It was further reported that the procedure was completed with another wire.There was no reported patient injury.
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| |
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