MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. GHIATAS LOCALIZATION WIRE; BIOPSY INSTRUMENT

Catalog Number 479201

Device Problem Signal Artifact/Noise (1036)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2016

Event Type  Injury  

Manufacturer Narrative

No device and no medical records 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.Images were provided and review is currently underway.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.

Event Description

It was reported that during a mri breast excision, the localization wire was allegedly displaying an artifact on the mri.Reportedly, the user proceeded with the wire in place and the amount of excised tissue area was enlarged.There was no reported patient injury.

Manufacturer Narrative

Manufacturing review: a manufacturing review was conducted.The lot met all release criteria.Visual inspection:the sample was not returned; therefore, visual inspection could not be performed functional/performance evaluation:the sample was not returned; therefore, functional evaluation could not be performed medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: based on the images provided, a blooming artifact was identified in both the coronal and sagittal views of an mri breast biopsy procedure, can be confirmed.Based on the images provided, it cannot be determined how much of the intended biopsy site was obscured by the blooming artifact, can be confirmed.Conclusion: per the reported event details, the biopsy clip was visualized under mri imaging.The current instructions for use (ifu) states, "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." it is possible that procedural issues and/or imaging techniques contributed to the reported event.However, based upon the available information, the definitive root cause is unknown.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.

Event Description

It was reported that during a mri breast excision, the localization wire was placed in targeted tissue and the coaxial needle was removed allegedly displaying an artifact on the mri.Reportedly, the user proceeded with the wire in place and the amount of excised tissue area was enlarged.There was no reported patient injury.

Manufacturer Narrative

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 inspection:the sample was not returned; therefore, visual inspection could not be performed functional/performance evaluation:the sample was not returned; therefore, functional evaluation could not be performed medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: based on the images provided, a blooming artifact was identified in both the coronal and sagittal views of an mri breast biopsy procedure, can be confirmed.Based on the images provided, it cannot be determined how much of the intended biopsy site was obscured by the blooming artifact, can be confirmed.Conclusion:per the reported event details, the biopsy clip was visualized under mri imaging.The current instructions for use (ifu) states, "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." it is possible that procedural issues and/or imaging techniques contributed to the reported event.However, based upon the available information, the definitive root cause is unknown.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.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.

Event Description

It was reported that during a mri breast excision, the localization wire was placed in targeted tissue and the coaxial needle was removed allegedly displaying an artifact on the mri.Reportedly, the user proceeded with the wire in place and the amount of excised tissue area was enlarged.There was no reported patient injury.

• Brand Name: GHIATAS LOCALIZATION WIRE
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6087869
• MDR Text Key: 59460509
• Report Number: 2020394-2016-01042
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 00801741079931
• UDI-Public: (01)00801741079931(17)181128(10)REZL0066
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2018
• Device Catalogue Number: 479201
• Device Lot Number: REZL0066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1900-2017
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention