MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA DILATATION CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	CQF75108
Medical Device Problem Codes	Break (1069); Material Puncture/Hole (1504); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the investigation is confirmed for a break in the shaft; however, the investigation is inconclusive for the reported retraction issues as the device was unable to be functionally tested due to the break in the shaft.Based upon the available information, the definitive root cause is unknown.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 cqf75108 pta balloon dilatation catheter allegedly experienced a break, material puncture, and a retraction problem.This information was received from a single source.The malfunction involved a patient with no reported consequence.The patient¿s age, weight, and sex were not provided.

• Brand Name: CONQUEST 40 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: 8796346
• Report Number: 2020394-2019-01538
• Device Sequence Number: 16602380
• Product Code: LIT
• UDI-Device Identifier: 00801741060649
• UDI-Public: (01)00801741060649
• 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): 07/16/2019

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: CQF75108
• Device Catalogue Number: CQF75108
• Device Lot Number: RECX1232
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/16/2019
• Patient Sequence Number: 1