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 a breast tissue marker was deployed into a very superficial lesion and pellets came out of the breast.The health care professional at the facility cleaned the biopsy site area and patient was referred to a surgical consult.

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 was not provided.The investigation is inconclusive, as the sample was not returned for evaluation.Per the event description, the marker was deployed into very superficial tissue, therefore it is possible that patient and/or procedural factors may have contributed to the reported event.However, based on available information, the definitive root cause could not be determined.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.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.

Manufacturer Narrative

To ensure compliance to 21 cfr 803.50 a retrospective review of this file was conducted to determine if good faith efforts were made to obtain the required information and/or an explanation of why any required information was not provided.The file was documented with the patient's sex, but not reported.Attempts were made to the user facility to obtain information pertaining to patient, product, and/or procedural details (e.G.Date of the event, relevant test data, relevant history, lot #, catalog #, implant and/or explanted dates, and concomitant product(s) or therapy) that were not previously obtained during the initial investigation.The user facility did not have any additional details to provide at this time.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.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): INFUS MEDICAL (THAILAND); 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; TH 10280
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 4909679
• MDR Text Key: 15389677
• Report Number: 2020394-2015-00901
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative,use
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/07/2014

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?: No
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 06/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2015
• 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