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

Model Number	DR4084
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A lot history review was conducted, and it was determined that a device history record (dhr) review was not required.The device was returned for evaluation.The device was inflated with water, and a leak was identified at the proximal balloon butt joint.A partial break at the butt joint was identified, resulting in the leak.Therefore, the investigation is confirmed for the reported leak, as well as for a break at the butt joint.The partial break at the glue butt joint resulted in the identified leak.However, the definitive root cause for the partial break could not be determined based upon available information.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model dr4084 pta balloon dilatation catheter allegedly leaked at the glue joint of the proximal end of the pta balloon.The balloon was removed and the procedure was concluded.No further treatment was provided.There was no reported patient injury.This information was received from one source.Patient age, weight, and gender were not provided.

• 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: 8809122
• Report Number: 2020394-2019-01631
• Device Sequence Number: 327433
• Product Code: DQY
• UDI-Device Identifier: 00801741059247
• UDI-Public: (01)00801741059247
• 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): 07/19/2019

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: DR4084
• Device Catalogue Number: DR4084
• Device Lot Number: 93VB0143
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/19/2019
• Patient Sequence Number: 1