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

Model Number DR8086

Device Problems Break (1069); Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided and a lot history review was conducted.The sample was returned for evaluation.The investigation confirmed for both the break and the inflation issue.The root cause could not be determined.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model dr8086, pta balloon dilatation catheter, allegedly experienced a break and an inflation issue.This information was received from a single source.This malfunction involved a (b)(6) year old male patient with no consequences.The patient's weight was 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: 9597450
• MDR Text Key: 178119043
• Report Number: 2020394-2020-00523
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741059292
• UDI-Public: (01)00801741059292
• 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: 01/16/2020

1 Device was Involved in the Event

1 Patient was 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: DR8086
• Device Catalogue Number: DR8086
• Device Lot Number: 93TD0152
• Date Manufacturer Received: 12/31/2019
• Type of Device Usage: N
• Patient Sequence Number: 1