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

Catalog Number	863017
Medical Device Problem Codes	Device Slipped (1584); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 09/2026) h11: 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
It was reported that prior to a breast tissue marker placement procedure, a foreign object was allegedly found in a sterile pack.There was no patient contact.
Event or Problem Description
It was reported that prior to a breast tissue marker placement procedure, small dust was allegedly found in the sterile pack.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the sample was not returned for evaluation.Four photos were provided and reviewed.The first photo shows the distal end of the device within the packaging.The needle protector was noted on the device.The one radiopaque marker with interwoven pva polymer was noted to be deployed outside the applicator.The second photo shows a label of an ultraclip ii tissue marker; product information was verified with trackwise.The third photo shows the sealed packaging of the ultraclip ii tissue marker.The applicator is noted to be in a locked initial position, the one radiopaque marker with interwoven pva polymer was noted to be deployed outside the applicator.The fourth is a duplicate image of the third photo with a circle around the one radiopaque marker with interwoven pva polymer was noted to be deployed outside the applicator.Therefore, based on the photo review, the reported failure device contamination could not be confirmed as the provided photos shows that the material is noted to be a wire-form.Therefore, the investigation is unconfirmed for the reported device contamination as the small dust which was referred to be a foreign material in the reported event is noted to be a wireform and the investigation is confirmed for the identified device slipped as the pva marker was noted to be deployed outside the applicator.A definitive root cause for the alleged device contamination and identified device slipped 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 (expiry date: 09/2026), g2, g3, h6 (device, method) h11: b5, e1, e3, h6 (result, conclusion) h11: 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.H3 other text : device not returned.

• Brand Name: ULTRACLIP
• 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: 18836589
• Report Number: 2020394-2024-00312
• Device Sequence Number: 20697551
• Product Code: GDW
• UDI-Device Identifier: 00801741032295
• UDI-Public: (01)00801741032295
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K042341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

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: 863017
• Device Lot Number: HUHX0341
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2023
• 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