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

Model Number	CQF7578
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction event.A review of the events indicated that model cqf7578 conquest 40 pta balloon dilatation catheter ruptured.Of this event, the device was used on the patient but the patient was not injured.The patient¿s age, sex, and weight were not provided.The cqf7578 conquest 40 pta balloon dilatation catheter was returned and is pending investigation.
Event or Problem Description
This report summarizes one malfunction.A review of the information indicated that model cqf7578 pta balloon dilatation catheter allegedly ruptured.The reported information was received from one source.Of this event, the device was used on the patient but the patient was not injured.The patient¿s age, sex, and weight were not provided.
Additional Manufacturer Narrative
For the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.A visual inspection found a partial circumferential rupture in the balloon and fibers.Therefore, the investigation is confirmed for a circumferential rupture.The definitive root cause for the identified circumferential rupture could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.The device was labeled for single use.

• Brand Name: CONQUEST 40 PTA BALLOON 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: 8525308
• Report Number: 2020394-2019-00468
• Device Sequence Number: 14142931
• Product Code: DQY
• UDI-Device Identifier: 00801741060519
• UDI-Public: (01)00801741060519
• 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,Followup
• Report Date (Section B): 07/23/2019

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: CQF7578
• Device Catalogue Number: CQF7578
• Device Lot Number: RECQ1799
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1