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

Model Number	U4200220RX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The results of the anticipated device evaluation will be provided upon completion of the event investigation.The information provided by bard 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 bard.
Event or Problem Description
It was reported that during an angioplasty procedure in the anterior tibial artery, the pta balloon allegedly detached at the proximal end after multiple inflation/deflation's.Upon detachment the balloon segment became lodged against the vessel wall of the abdominal aorta.Multiple attempts to remove the balloon segment including the use of a snare were unsuccessful.The health care provider decided to open the patients femoral artery and successfully retrieved the balloon segment.The vessel was reported to be patent with good blood flow at the conclusion of the angioplasty procedure.The patient was reported to be doing well post procedure.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: the device was not returned, however two electronic photos and one radiopaque image were provided for review.Based on the photo review, the investigation can be confirmed for a complete detachment of the catheter shaft.The distal portion of the catheter shaft and balloon were not visible in the provided photos.Therefore, the investigation is inconclusive for the reported balloon detachment.The completed image review could not confirm the reported issue.The definitive root cause for the identified detachment could not be determined based upon available information.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: 11/2018.(conclusion1) patient code changed to (b)(4).
Event or Problem Description
It was reported that during an angioplasty procedure in the anterior tibial artery, the pta balloon allegedly detached at the proximal end after multiple inflation/deflation's.Upon detachment the balloon segment became lodged against the vessel wall of the abdominal aorta.Multiple attempts to remove the balloon segment including the use of a snare were unsuccessful.The health care provider decided to open the patients femoral artery and successfully retrieved the balloon segment.The vessel was reported to be patent with good blood flow at the conclusion of the angioplasty procedure.The patient was reported to be doing well post procedure.

• Brand Name: ULTRAVERSE RX 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: 7422141
• Report Number: 2020394-2018-00368
• Device Sequence Number: 16282349
• Product Code: LIT
• UDI-Device Identifier: 00801741056338
• UDI-Public: (01)00801741056338
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K131199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2018

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: U4200220RX
• Device Catalogue Number: U4200220RX
• Device Lot Number: 50132575
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 04/11/2018
• Supplement Report FDA Received Date: 07/25/2018
• 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: 71 YR