MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. GELMARK ULTRA BREAST TISSUE MARKER; BIOPSY INSTRUMENT

Catalog Number	GMUEC10GSS
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Poor Quality Image (1408); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one gelmark ultra marker applicator was received with their tip guide.During visual evaluation, the device appeared to have residue throughout.Also the marker applicator was noted to be in a pre- deployed configuration and no pads were present.Slight bend noted to the proximal end of the plunger, a circumferential break was noted to the distal end of the marker applicator.Under x-ray examination, the returned device was noted to have a marker stuck at the distal end of the marker applicator.No other anomalies were noted.Due to the condition of the returned device, no functional testing performed.Therefore, the investigation is confirmed for the reported bent as returned device was noted to be bent and the investigation is inconclusive for positioning failure due to the condition of the returned device (identified break).The investigation is unconfirmed for poor image quality as under x-ray evaluation, the wire-form was noted to be stuck at the distal end of the marker applicator.The investigation is confirmed for the identified break issue as a circumferential break was noted to the distal end of the marker applicator.A definitive root cause for the alleged failure to deploy, poor quality image, bent needle and identified break issues could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f ¿ the information provide by bd represents all 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 bd.
Event or Problem Description
It was reported that during a breast tissue marker placement procedure, the marker was allegedly not placed smoothly.It was further reported that the inserted marker clip was not seen.Furthermore, the entire needle was allegedly skewed when it was pulled out.There was no reported patient injury.

• Brand Name: GELMARK ULTRA BREAST TISSUE MARKER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): INFUS MEDICAL (THAILAND); 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; TH 10280
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 20629045
• Report Number: 2020394-2024-01668
• Device Sequence Number: 7337008
• Product Code: FZP
• UDI-Device Identifier: 00801741031854
• UDI-Public: (01)00801741031854
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K011402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: GMUEC10GSS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2024
• Initial Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown