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

Catalog Number GMUEC10GSS

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 during a stereotactic breast biopsy procedure, a brest tissue marker was implanted.Images taken after marker placement which demonstrated migration of the marker.The breast was compressed prior to marker deployment.No patient injury was 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.The marker was not returned for evaluation; however, two cds of images were returned and reviewed.It is unknown whether the marker is placed at the intended site or if it had migrated whether the marker is placed at the intended site or if it had migrated, as no comparison images were provided.Based on the images provided, marker migration cannot be confirmed.Based on the available information, the complaint investigation is inconclusive and the definiitve root cause is unknown.It is unknown if patient and/or procedural issues contributed to the reported event.The current gel mark ultra 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: GEL MARK ULTRA MARKER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; tempe AZ
• Manufacturer (Section G): INFUS MEDICAL (THAILAND); 700 moo 4, bangpoo industrial estate; samutprakarn province 1028 0; TH 10280
• Manufacturer Contact: linda morocho ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4909739
• MDR Text Key: 15563935
• Report Number: 2020394-2015-00960
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K011402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/22/2013

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 Expiration Date: 10/31/2013
• Device Catalogue Number: GMUEC10GSS
• Device Lot Number: VT12H0937
• 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
• Date Device Manufactured: 08/01/2012
• 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