MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 018 PTA BALLOON DILATATION CATHETER

Model Number	U875610
Medical Device Problem Codes	Entrapment of Device (1212); Material Rupture (1546)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number for the device was not provided.The device history records could not be performed.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during an angioplasty procedure of a highly calcified lesion, the pta balloon allegedly ruptured just after inflation.The device was retrieved successfully by surgical intervention.There was no further patient injury.No further treatment was necessary.
Event or Problem Description
It was reported that during an angioplasty procedure of a highly calcified lesion in the femoral artery, the pta balloon allegedly ruptured and could not be removed.The detached material was retrieved successfully by surgical intervention.No further treatment was necessary.There were no further reported complications.
Additional Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be conducted, as the lot number was not reported for this device.Investigation summary: the device was returned for evaluation.A visual inspection found bunching along the outer catheter shaft and also found that the guidewire and inner lumen had been cut at the distal end of the device and that the balloon was missing.Therefore, the investigation is inconclusive for the reported balloon rupture and inconclusive for the reported entrapment based on the returned condition of the device.Per the reported event details, it is likely that the highly calcified lesion could have contributed to the reported balloon rupture and consequently the reported entrapment.However, the definitive root cause for the reported balloon rupture or the reported entrapment could not be determined based upon the available information.It is unknown whether patient and/or procedural issues contributed to the events.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.

• Brand Name: ULTRAVERSE 018 PTA BALLOON DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 8628558
• Report Number: 2020394-2019-00582
• Device Sequence Number: 2293061
• Product Code: LIT
• UDI-Device Identifier: 00801741055331
• UDI-Public: (01)00801741055331
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2019

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: U875610
• Device Catalogue Number: U875610
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 05/21/2019
• Supplement Report FDA Received Date: 11/20/2019
• 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