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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

After further clinical review of this event with bard's medical department, this event was reassessed and determined to be mdr reportable as a malfunction pursuant to 21 cfr part 803.A mfg review could not be performed, as the lot number is unk.The investigation is inconclusive, as the sample was not returned for eval.The root cause could not be determine based upon available info.The ghiatas beaded breast localization wire ifu includes instructions for use, warnings and precautions.The info provided by bard represents all of the known info at this time.Despite good faith efforts to obtain additional info, the complainant/ reporter was unable or unwilling to provide any further pt, product, or procedural details to bard.

Event Description

It was reported that a wire migrated approximately 4 cm.No further info was provided.There was no pt injury reported.

• Brand Name: GHIATAS BEADED BREAST LOCALIZATION WIRE
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd. montebello #1; parque industrial colonial ; reynosa, tamaulipas ; MX
• Manufacturer Contact: linda morocho ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 5007273
• MDR Text Key: 24269933
• Report Number: 2020394-2015-01220
• Device Sequence Number: 1
• Product Code: GAA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Physician
• Report Date: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1