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

Model Number	DR8064
Medical Device Problem Codes	Break (1069); Material Rupture (1546); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was returned for evaluation.The lot history review was performed.The investigation confirmed for the identified leak and partial circumferential break at the butt joint; unconfirmed for the reported balloon rupture an guidewire issue.A root cause has not been determined.The device is labeled for single use.(b)(4).
Event or Problem Description
This report summarizes one malfunction.The information reviewed indicated that model dr8064 pta balloon dilatation catheter allegedly experienced rupture, device-device incompatibility, break, and leak.This report was receive from once source.This device was used in a 69 year old male patient; weight was not provided.There was no reported patient injury.

• Brand Name: DORADO PTA DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9199306
• Report Number: 2020394-2019-04021
• Device Sequence Number: 19570723
• Product Code: DQY
• UDI-Device Identifier: 00801741058721
• UDI-Public: (01)00801741058721
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/16/2019

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
• Operator of Device: No Information
• Device Model Number: DR8064
• Device Catalogue Number: DR8064
• Device Lot Number: 93XB0069
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/16/2019
• Patient Sequence Number: 1