MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DORADO PTA DILATATION CATHETER

Model Number DR8064

Device Problems Peeled/Delaminated (1454); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Malfunction  

Manufacturer Narrative

For the reported event, lot number was provided, and lot history review. The sample was returned for evaluation. Balloon rupture, and peeling pebax was confirmed for the device. A root cause has not been determined. The device was labeled for single use.

Event Description

This report summarizes one malfunction. A review of the reported information indicated that model dr8064. Pta balloon dilatation catheter allegedly experienced material rupture and peeled. This report was received from a single source. This event did involve patient with no reported patient injury. Age, weight, and gender were not provided for the patient.

• Brand Name: DORADO PTA DILATATION CATHETER
• Type of Device: DORADO PTA 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: 9597314
• MDR Text Key: 178117870
• Report Number: 2020394-2020-00517
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (Y/N): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer

Reporter Occupation

• Type of Report: Initial
• Report Date: 01/16/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 01/16/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: NO INFORMATION
• Device MODEL Number: DR8064
• Device Catalogue Number: DR8064
• Device LOT Number: 93ND0098
• Was Device Available For Evaluation?: No Answer Provided

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/31/2019
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided

Is this a Reprocessed and Reused Single-Use Device?

Type of Device Usage