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

Model Number	CQF7554
Medical Device Problem Codes	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
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 confirmed for the reported balloon rupture, as a pinhole rupture was noted to the balloon, additionally the investigation also confirmed for the identified peeling pebax.The definitive root cause for the balloon rupture and peeled pebax could not be determined based upon available information.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the malfunction indicated that model cqf7554 pta balloon dilatation catheter allegedly peeled and experienced material rupture.This report was received from one source.This event involved a patient with no patient consequences.Age, weight, and gender were not provided for this patient.

• 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: 9596527
• Report Number: 2020394-2020-00455
• Device Sequence Number: 2525706
• Product Code: LIT
• UDI-Device Identifier: 00801741060397
• UDI-Public: (01)00801741060397
• 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): 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
• Operator of Device: No Information
• Device Model Number: CQF7554
• Device Catalogue Number: CQF7554
• Device Lot Number: REDR4138
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/16/2020
• Patient Sequence Number: 1