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

Model Number	CQ7568
Medical Device Problem Codes	Inflation Problem (1310); Peeled/Delaminated (1454); 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 device history review was performed.The sample was returned to the manufacturer for inspection/evaluation.Investigation of the received sample confirmed the alleged malfunction.Balloon rupture was noted to be the likely root cause for the inflation issue.However, the definitive root cause for the balloon rupture and peeled pebax could not be determined based on available information.It is unknown whether patient or procedural issues contributed to the event.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 cq7568 pta dilatation catheter allegedly experienced pinhole balloon rupture and had inflation issue.This information was received from one source.Of the one malfunction, one patient was involved with no patient consequence or impact.The patient was reported to be a (b)(6) year old female weighing (b)(6) lbs.

• Brand Name: CONQUEST 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: 10286847
• Report Number: 2020394-2020-04559
• Device Sequence Number: 515449
• Product Code: DQY
• UDI-Device Identifier: 00801741062919
• UDI-Public: (01)00801741062919
• 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): 07/16/2020

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: CQ7568
• Device Catalogue Number: CQ7568
• Device Lot Number: REDU0438
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/16/2020
• Patient Sequence Number: 1