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

Model Number	DR135102
Medical Device Problem Codes	Break (1069); Inflation Problem (1310)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the complaint history review (chr), this is the first complaint reported for this lot number.Received one dorado catheter in a sample return kit.A complete circumferential split was noted at the butt joint between the balloon and catheter.The balloon was held on by the guidewire lumen.The definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.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 dr135102 pta balloon dilatation catheter allegedly experienced an inflation issue and break.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: 8814305
• Report Number: 2020394-2019-01725
• Device Sequence Number: 11397097
• Product Code: DQY
• UDI-Device Identifier: 00801741059513
• UDI-Public: (01)00801741059513
• 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): 07/22/2019

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
• Operator of Device: No Information
• Device Model Number: DR135102
• Device Catalogue Number: DR135102
• Device Lot Number: 93PD0088
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/22/2019
• Patient Sequence Number: 1