MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 035; PTA BALLOON DILATATION CATHETER

Model Number	U3575104
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/09/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.Three photo's was reviewed.The first photo shows a fully deflated balloon, a guide wire and a another balloon which has compound ruptured and the balloon noted to detached distally form the catheter.The second photo shows the same fully deflated balloon, a guide wire and a another balloon which has compound ruptured and the balloon noted to detached distally form the catheter.The third photo shows the ruptured balloon (compound rupture) and distally detached from the catheter, marker bands are present in the catheter.No other specific anomalies.Therefore based on the submitted photo's balloon rupture and balloon detachment can be confirmed.Therefore based on the photo review the investigation was confirmed for the reported balloon rupture as the balloon has a compound rupture was noted.The investigation was also confirmed for the reported balloon detachment as the balloon detached from the catheter distally from the submitted photo's.A definitive root cause for the reported balloon rupture and identified balloon detachment could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.Device not returned.
Event or Problem Description
It was reported that post angioplasty procedure to treat a very tight stenosis in the axillary vein, the balloon allegedly ruptured and tore apart during removal of device from the patient.It was further reported that even after multiple attempts to recover the torn device, a small piece of the balloon was left behind and was unrecoverable.The patient was reported to be in a stable condition.

• Brand Name: ULTRAVERSE 035
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• MDR Report Key: 12273440
• Report Number: 2020394-2021-01423
• Device Sequence Number: 17136437
• Product Code: LIT
• UDI-Device Identifier: 00801741094583
• UDI-Public: (01)00801741094583
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K142261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/10/2021

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 Model Number: U3575104
• Device Catalogue Number: U3575104
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2021
• Initial Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention