MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. GHIATAS BEADED BREAST LOCALIZATION WIRE; GUIDE, NEEDLE, SURGICAL

Catalog Number	477201
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2015
Type of Reportable Event	Malfunction
Additional 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 lot history review was conducted, which indicated that a device history record (dhr) review was not required.Visual inspection: a visual inspection was not performed as the sample was not returned.Functional/performance evaluation: functional testing was not performed as the sample was not returned medical records review: a medical records review was not performed as no medical records were provided.Image/photo review: images were provided for review.Based on the images review, the reported artifact can be confirmed.Conclusion: although the sample was not returned for evaluation, images were provided for review.Based on the images review, the reported artifact can be confirmed.Therefore, the investigation is confirmed for the reported event.The definitive root cause could not be determined based upon available information.It is unknown whether procedural factors contributed to the event.Labeling review: a labeling review was not performed.H11:section a through f - 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 or Problem Description
It was reported that allegedly during a breast localization wire placement into normal tissue density, the health care provider was unable to confirm the placement of the wire because of the alleged blooming artifact from the wire.There was no report of patient injury.

• Brand Name: GHIATAS BEADED BREAST LOCALIZATION WIRE
• Common Device Name: GUIDE, NEEDLE, SURGICAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6596021
• Report Number: 2020394-2017-00529
• Device Sequence Number: 10786164
• Product Code: GDF
• UDI-Device Identifier: 00801741079924
• UDI-Public: (01)00801741079924(17)170331(10)REYB1777
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2017
• Device Catalogue Number: 477201
• Device Lot Number: REYB1777
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2017
• Initial Report FDA Received Date: 05/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1900-2017
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 79