MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR INC. BARD; VIDA PTV DILATATION CATHETER

Model Number VDA100164

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/16/2019

Event Type  Injury  

Event Description

Pt underwent balloon angioplasty, the balloon ruptured sheared from the catheter.

• Brand Name: BARD
• Type of Device: VIDA PTV DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR INC. ; 1625 west 3rd street; tempe AZ 85281
• MDR Report Key: 8936164
• MDR Text Key: 155818275
• Report Number: 8936164
• Device Sequence Number: 1
• Product Code: OMZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2020
• Device Model Number: VDA100164
• Device Catalogue Number: VDA100164
• Device Lot Number: 93X80155
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2019
• Distributor Facility Aware Date: 08/19/2019
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 91