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

Model Number	DR8084
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454); 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 four reported malfunctions were provided, therefore, a lot history reviews were performed.Of the four devices, two devices were returned for evaluation.Therefore, the investigation is confirmed for the peeled pebax issue, catheter leak and glue joint break.However, the investigation is unconfirmed for balloon rupture.Based on the available information, the definitive root cause is unknown.The devices are labeled for single use.(b)(4).
Event or Problem Description
This report summarizes four malfunctions.A review of the reported information indicates that model dr8084 pta balloon dilatation catheter allegedly experienced material rupture, break,leak and peeled or delaminated.The information was received from a single source.One patient was involved with no reported patient injury.The patients¿ 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: 11205191
• Report Number: 2020394-2021-80010
• Device Sequence Number: 2947331
• Product Code: LIT
• UDI-Device Identifier: 00801741059254
• UDI-Public: (01)00801741059254
• 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): 01/20/2021

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: DR8084
• Device Catalogue Number: DR8084
• Device Lot Number: 93TE0015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 01/20/2021
• Patient Sequence Number: 1