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

Model Number DR8076

Device Problems Break (1069); Inflation Problem (1310); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review was performed.Received one dorado pta catheter.The catheter was kinked throughout.A complete circumferential break was noted at the butt joint of the balloon and catheter.Based upon the available information, the definitive root cause is unknown the device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model dr8076 pta balloon dilatation catheter was allegedly difficult to inflate and allegedly leaked and broke.This information was received from a single source.The alleged malfunction involved a patient with no known impact to the patient.The patient was reported to be a (b)(6) year-old male, weighing (b)(6).

• 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8811770
• MDR Text Key: 151733064
• Report Number: 2020394-2019-01653
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741059025
• UDI-Public: (01)00801741059025
• 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: 07/22/2019

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 Model Number: DR8076
• Device Catalogue Number: DR8076
• Device Lot Number: 93WC0092
• Initial Date Manufacturer Received: 06/30/2019
• Initial Date FDA Received: 07/22/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1