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

Model Number	477201
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number of the device was provided.The device history records are currently under review.The return of the sample is pending.The photo review is currently underway review.The investigation is currently underway.(expiry date: 02/2022).
Event or Problem Description
It was reported that post placement of a localization wire, an artifact allegedly was found on mri imaging.It was further reported that the procedure was completed with another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Additionally, it was determined that no action is required based on the number of events associated with this lot number.Investigation summary: one ghiatas localization wire was returned for evaluation and two mr images were provided for review.The returned sample could not be functionally evaluated as the conditions of use could not be replicated (i.E.Mr imaging with parameters used during procedure).Per the image review performed, an artifact was identified in the first mr image provided with minimal artifact identified in the second image provided.As such, the investigation is confirmed for the reported artifact.Per the ghiatas instructions for use, "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." as such, it is possible that imaging parameters contributed to the reported artifact.However, the definitive root cause could not be determined based upon available information.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that post placement of a localization wire, an artifact allegedly was found on mri imaging.It was further reported that the procedure was completed with another device.The current patient status is unknown.

• Brand Name: GHIATAS LOCALIZATION WIRE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8937675
• Report Number: 2020394-2019-02984
• Device Sequence Number: 16274945
• Product Code: GDF
• UDI-Device Identifier: 00801741079924
• UDI-Public: (01)00801741079924
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 477201
• Device Catalogue Number: 477201
• Device Lot Number: REDQ4074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention