MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRACLIP DUAL TRIGGER; BIOPSY INSTRUMENT

Catalog Number	864017D
Medical Device Problem Codes	Difficult to Remove (1528); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H11: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.Section a through f - the information provided by bd 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 bd.
Event or Problem Description
On (b)(6) 2025, a patient underwent an ultrasound guided breast tissue marker placement procedure using the ultraclip dual trigger via percutaneous puncture.During the procedure, it was reported that the needle tube was allegedly clamped the tissue.During withdrawal, it was further reported that the tissue and the marker was removed together.No coaxial biopsy needle was used, and the procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the physical device was not returned for evaluation.One photo was provided and it was reviewed.In that photo, one ultraclip dual trigger was presented inside its package and also a marker was observed within the distal tip of its needle.Based on the provided photo, the reported separation failure can be confirmed and the reported difficult to remove cannot be confirmed.Therefore, the investigation is confirmed for the reported separation as the provided photo shows the marker noted within the needle's tip and the investigation is inconclusive for the reported difficult to remove as no objective evidence was provided to support the reported event.A definitive root cause for the alleged separation failure and difficult to remove issue 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.G3, h6 (component, method, result, conclusion).Section a through f - the information provided by bd 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 bd.
Event or Problem Description
On (b)(6) 2025, a patient underwent an ultrasound guided breast tissue marker placement procedure using the ultraclip dual trigger via percutaneous puncture.During the procedure, it was reported that the needle tube was allegedly clamped the tissue.During withdrawal, it was further reported that the tissue and the marker was removed together.No coaxial biopsy needle was used and the procedure was completed using another device.There was no reported patient injury.

• Brand Name: ULTRACLIP DUAL TRIGGER
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23121066
• Report Number: 2020394-2025-01554
• Device Sequence Number: 18496001
• Product Code: NEU
• UDI-Device Identifier: 00801741032257
• UDI-Public: (01)00801741032257(17)270728(10)HUJV0919
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K090547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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: 864017D
• Device Lot Number: HUJV0919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 09/23/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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