MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRAVERSE 014 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	U415034
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	06/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: the device was returned for evaluation.A visual inspection was performed and the balloon was noted to be circumferentially rupture, with the distal portion of the balloon not returned.The inner lumen was noted to be broken distally from the balloon rupture, and appeared to be stretched before the break.The distal portion of the inner lumen was not returned.Therefore, the investigation is confirmed for the identified balloon and tip detachment., as both were detached from the device and not returned.The investigation is confirmed for the identified balloon rupture, as a circumferential rupture was noted to the balloon.The definitive root cause for the identified balloon and tip detachment and balloon rupture could not be determined based upon available information.It is unknown whether patient or procedural issues contributed to the event.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.(expiry date: 12/2021).
Event or Problem Description
It was reported that during an angioplasty procedure of the tibial artery, the tip of the pta balloon allegedly detached.It was further reported that a stent was used to oppose the detached tip to the vessel wall.The patient was reported as stable.

• Brand Name: ULTRAVERSE 014 PTA 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: 9200241
• Report Number: 2020394-2019-04046
• Device Sequence Number: 11527508
• Product Code: LIT
• UDI-Device Identifier: 00801741053689
• UDI-Public: (01)00801741053689
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K121856
• 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): 10/16/2019

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: U415034
• Device Catalogue Number: U415034
• Device Lot Number: CMDN0353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 10/16/2019
• 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
• Patient Age: 85 YR
• Patient Weight: 66