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

Catalog Number VA80104

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Of the three devices, 2 lot numbers were provided, and lot history reviews were performed.Of the three reported malfunctions, devices were not returned for evaluation; however, two photos were provided.For one malfunction, the investigation is confirmed for retraction problem.For the remaining two malfunctions, the investigation is inconclusive for retraction problem.Based upon the available information, the definitive root cause is unknown.The devices were labeled for single use.

Event Description

This report summarizes three malfunctions.A review of the reported information indicates that model va80104 pta dilatation catheter allegedly experienced retraction problem.The information was received from various sources.All three malfunctions involved patients with no patient consequences.The age, weight, and gender were not provided for all three patients.

• Brand Name: VACCESS PTA DILATATION CATHETER
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens TX 75751
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10311561
• MDR Text Key: 199979154
• Report Number: 2020394-2020-04972
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: VA80104
• Device Lot Number: 93NE0032, 93TD0100, UNKNOWN
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/22/2020
• Type of Device Usage: N
• Patient Sequence Number: 1