MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE RX; PTA BALLOON DILATATION CATHETER

Catalog Number	U42001H8RX
Medical Device Problem Codes	Break (1069); Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/05/2024
Type of Reportable Event	Serious 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 evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2025) 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 an angioplasty procedure, the pta balloon was allegedly did not break but the support shaft broke.It was further reported that the distal balloon was detached by virtue of the mid-shaft break.Reportedly, the detached component required open cut-down and retrieval.The procedure was completed using another balloon.The current status of the patient is stable.
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.Two photos were received and reviewed.The first photo shows the outer packaging box of ultraverse rx.The labeling details in the box matched with the details provided in trackwise.The second photo shows the ultraverse rx balloon catheter with blood residues.The detachment is noted in the proximal end of the balloon.Therefore, the investigation is confirmed for the reported detachment issue as detachment was noted in the proximal end of the balloon.However, the investigation remains inconclusive for the reported lesion advancement issue as no objective evidence was provided for review.A definitive root cause for the alleged detachment issue and lesion advancement 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: g3, h6 (method).H11: b5, d4 (unique identifier (udi) #), h6 (device, result, conclusion).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 an angioplasty procedure, allegedly there was resistance when advancing the balloon up, over the aortic bifurcation when the support shaft of pta balloon was allegedly broken.It was further reported that the distal balloon was detached by virtue of the mid-shaft break.Reportedly, the detached component required open cut-down and retrieval.The procedure was completed using another balloon.The current status of the patient is stable.

• Brand Name: ULTRAVERSE RX
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 20356785
• Report Number: 2020394-2024-01528
• Device Sequence Number: 7283931
• Product Code: LIT
• UDI-Device Identifier: 00801741055942
• UDI-Public: (01)00801741055942(17)251031(10)CMGY0081
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K131199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2025
• Device Catalogue Number: U42001H8RX
• Device Lot Number: CMGY0081
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 02/11/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown