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

Catalog Number	864017DL
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a breast tissue marker placement procedure, the marker button allegedly slid to the lesion site where the coil allegedly got stuck to the needle when it was retracted from the lesion.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: received one ultraclip dual trigger breast tissue marker for evaluation.Upon visual evaluation the device appeared to have residue throughout the needle.The wire-form was not returned, and it was noted that the device came back fully deployed, no markers were returned with the device and also gaps were noted to the front and back seams of the device.Further functional testing was not performed due to the nature of the complaint.Therefore, the investigation is inconclusive for the reported failure as the functional testing was not performed and investigation is confirmed for the identified detachment of device issue as the gaps were noted to the front and back seams of the device.A definitive root cause for the alleged separation failure and identified detachment 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.H10: d4 (expiration date: 08/2025).H11: section a through f ¿ the information provided 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.H3 other text : see h10.

• 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: 18839476
• Report Number: 2020394-2024-00315
• Device Sequence Number: 7181542
• Product Code: NEU
• UDI-Device Identifier: 00801741032264
• UDI-Public: (01)00801741032264
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K090547
• 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): 02/29/2024

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: 864017DL
• Device Lot Number: HUGW2219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 03/05/2024
• 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