MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. GWEL MARK ULTRA MARKER

Catalog Number UNK GELMARK

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that following three different stereotactic breast biopsy procedures performed over several weeks time frame, the marker was placed into the breast under compression and during the post mammogram, it was discovered that the marker had migrated.One of the patients was taken back to the procedure room, and another marker was placed under ultrasound guidance; however the other two patients did not receive another clip/marker.The migration of the clip was documented in their files.There was no patient injury reported.

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 manufacturing review was conducted and the reported lot met all release criteria.This is the first complaint for this lot number and issue to date.The investigation is inconclusive, as the sample was not returned for evaluation.It is unknown if patient and/or procedural issues contributed to the reported event.Based on the available information, the definitive root cause is unknown.The current gel mark ultra breast biopsy marker instructions for use (ifu) provides general instructions for use of the device, as well as warnings, precautions, and potential complications associated with the device.A-d: 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.

• Brand Name: GWEL MARK ULTRA MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): SENORX, INC.; 3 morgan; irvine CA 92618 191
• Manufacturer Contact: linda morocho ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4909765
• MDR Text Key: 6052420
• Report Number: 2020394-2015-00949
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/10/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK GELMARK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 06/24/2015
• 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