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

Model Number DR8084

Device Problems Break (1069); Peeled/Delaminated (1454); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the four reported malfunctions were provided, therefore, a lot history reviews were performed.Of the four devices, two devices were returned for evaluation.Therefore, the investigation is confirmed for the peeled pebax issue, catheter leak and glue joint break.However, the investigation is unconfirmed for balloon rupture.Based on the available information, the definitive root cause is unknown.The devices are labeled for single use.(b)(4).

Event Description

This report summarizes four malfunctions.A review of the reported information indicates that model dr8084 pta balloon dilatation catheter allegedly experienced material rupture, break,leak and peeled or delaminated.The information was received from a single source.One patient was involved with no reported patient injury.The patients¿ age, weight, and gender were not provided.

• Brand Name: DORADO 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: 11205191
• MDR Text Key: 227924786
• Report Number: 2020394-2021-80010
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741059254
• UDI-Public: (01)00801741059254
• 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: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DR8084
• Device Catalogue Number: DR8084
• Device Lot Number: 93TE0015
• Date Manufacturer Received: 12/31/2020
• Type of Device Usage: N
• Patient Sequence Number: 1