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

Model Number	CQF7578
Medical Device Problem Codes	Material Frayed (1262); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.Circumferential rupture and frayed fibers were identified on the returned device.Based on the available information, the definitive root cause for this event 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 cqf7578 pta diliatation catheter allegedly experienced material rupture and frayed material.This information was received from one source.The one reported malfunction involved one patient with no consequences.The age and weight of the female patient was not provided.

• Brand Name: CONQUEST 40 PTA DILATATION CATHETER
• Common Device Name: PTA DILIATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10749735
• Report Number: 2020394-2020-06177
• Device Sequence Number: 14317004
• Product Code: DQY
• UDI-Device Identifier: 00801741060519
• UDI-Public: (01)00801741060519(17)220831
• 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): 10/28/2020

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: CQF7578
• Device Catalogue Number: CQF7578
• Device Lot Number: REDW1356
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/28/2020
• Patient Sequence Number: 1