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 Date 04/24/2013

Event Type  malfunction  

Event Description

It was reported that following a breast biopsy procedure, a marker was placed and the initial image showed the marker was not in the expected position and a second image showed the marker 5 cm away from the biopsy site.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 could not be performed, as the lot number is unknown.The marker was not returned for evaluation.Based on the results of the image review, the complaint investigation is inconclusive.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.Eleven mammogram images were reviewed and no labeling or text annotations identifying anatomical projections or the time the images were taken are displayed on the images; therefore, no comparison between any images can be made.Based on the images provided, marker migration cannot be confirmed.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): SENORX, INC. (BPV); 1625 w. 3rd street; tempe AZ 85281
• Manufacturer Contact: linda morocho ; 1625 west 3rd st.; tempe, AZ 85281 ; 4808949515
• MDR Report Key: 4909719
• MDR Text Key: 6833981
• Report Number: 2020394-2015-00891
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K011402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2013

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 Catalogue Number: GMUEC10GSS
• 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