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

Model Number	DR80610
Medical Device Problem Codes	Inflation Problem (1310); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device were provided, a manufacturing review was performed.The sample was not returned to the manufacturer for evaluation.The investigation was inconclusive for the reported balloon rupture and failure to inflate.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that the model dr80610 pta dilatation catheter allegedly failed to inflate and balloon ruptured.This information was received from one source.The malfunction involved patient with no known impact to the patient.The patient's age, sex and weight were unknown.

• 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: 10286733
• Report Number: 2020394-2020-04539
• Device Sequence Number: 485720
• Product Code: DQY
• UDI-Device Identifier: 00801741058837
• UDI-Public: (01)00801741058837
• 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): 07/16/2020

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: DR80610
• Device Catalogue Number: DR80610
• Device Lot Number: 93TD0039
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/16/2020
• Patient Sequence Number: 1