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

Catalog Number UNK ULTRAVERSE 014

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Vessels (2135); Vascular Dissection (3160); Embolism/Embolus (4438)

Event Date 08/23/2021

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Event Description

It was reported through an anonymous post-market survey of percutaneous transluminal angioplasty (pta) catheters that out of 443 total treatments, 2 were unsuccessful in renal, 7 were unsuccessful in femoral, 3 were unsuccessful in popliteal, 7 were unsuccessful in tibial, 156 were unsuccessful in peroneal and there were 7 occurrences of flow-limiting dissection, 5 occurrences of vessel perforation and 5 occurrences of distal embolization which required intervention.The current status of the patient(s) was not provided.

Event Description

It was reported through an anonymous post-market survey of percutaneous transluminal angioplasty (pta) catheters that out of two hundred and ninety-three total treatments, two were unsuccessful in renal, seven were unsuccessful in femoral, three were unsuccessful in popliteal, seven were unsuccessful in tibial, eleven were unsuccessful in peroneal and there were seven occurrences of flow-limiting dissection, five occurrences of vessel perforation and five occurrences of distal embolization which required intervention.The current status of the patient(s) was not provided.

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the device was not returned for evaluation.Therefore, the investigation is inconclusive, as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.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.H11:section a through f - the information provided by bd 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 bd.H3 other text : device not returned.

• Brand Name: ULTRAVERSE 014
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12481266
• MDR Text Key: 271702703
• Report Number: 2020394-2021-01696
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• PMA/PMN Number: K121856
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ULTRAVERSE 014
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention