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

Model Number	DR135510
Medical Device Problem Codes	Material Frayed (1262); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported malfunction, a lot number was provided, and a lot history review was performed.The sample was returned for evaluation.After further evaluation, the investigation is confirmed for the reported device-device incompatibility, for the catheter kink (material deformation) and for the frayed material.The definitive root cause 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 malfunction indicated that model dr135510 pta balloon dilatation catheter allegedly experienced device-device incompatibility, material frayed and material deformation.This report was received from one source.This malfunction involved a patient with no patient consequences.The device was used in a (b)(6) year-old female patient, (b)(6) lbs.

• 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: 9596864
• Report Number: 2020394-2020-00490
• Device Sequence Number: 3604370
• Product Code: DQY
• UDI-Device Identifier: 00801741058592
• UDI-Public: (01)00801741058592
• 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): 01/16/2020

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: DR135510
• Device Catalogue Number: DR135510
• Device Lot Number: 93SD0029
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/16/2020
• Patient Sequence Number: 1