MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRASCORE 035; FOCUSED FORCE PTA BALLOON

Catalog Number	US3513068
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure in the popliteal artery via left groin, the pta balloon allegedly failed to cross the lesion.It was further reported that the pta balloon was allegedly difficult to be removed and had very hard resistance.It was further reported that the wires allegedly detached from the balloon.The procedure was completed using another device.There was no reported patient injury.
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 inspection/evaluation.However, images were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 09/2025) 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.
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: the physical device was not returned for evaluation.Six image were reviewed.The first image shows an artery with a wire through it and moderate stenosis.The second images show the artery with no wire.The third demonstrates a balloon that is partially dilated across a lesion with an air bubble in the balloon.The fourth image is the artery with a wire.The fifth is an image with a balloon across the artery and the final image with a balloon partially dilated.As no substantial evidence of any reported failure couldn't be noted on the submitted images hence the investigation remains inconclusive for the reported lesion advancement failure, balloon catheter removal issue and scoring wire detachment.A definitive root cause for the reported lesion advancement failure, balloon catheter removal issue and scoring wire detachment 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: b5, d4: (expiration date: 09/2025), g3, h6 (method).H11: e3, h6 (result, conclusion).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.
Event or Problem Description
It was reported that during an angioplasty procedure in the severely calcified stenosis of a popliteal artery via the left groin, the pta balloon allegedly failed to cross the lesion.It was further reported that the pta balloon was allegedly difficult to be removed and had very hard resistance.It was further reported that the wires allegedly detached from the balloon.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: ULTRASCORE 035
• Common Device Name: FOCUSED FORCE PTA BALLOON
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18738972
• Report Number: 2020394-2024-00231
• Device Sequence Number: 17952808
• Product Code: PNO
• UDI-Device Identifier: 00801741116865
• UDI-Public: (01)00801741116865
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K172571
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2024

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: US3513068
• Device Lot Number: GFHW0451
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 04/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 87 YR
• Patient Sex: Female