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

Model Number DR135510

Device Problems Material Frayed (1262); Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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
• Type of Device: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens TX 75751
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9596864
• MDR Text Key: 178326183
• Report Number: 2020394-2020-00490
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741058592
• UDI-Public: (01)00801741058592
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: DR135510
• Device Catalogue Number: DR135510
• Device Lot Number: 93SD0029
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/16/2020
• Type of Device Usage: N
• Patient Sequence Number: 1