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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. CONQUEST 40 PTA DILATATION CATHETER PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number CQF7554
Device Problems Peeled / Delaminated; Material Rupture
Event Type  Malfunction  
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 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.

 
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Brand NameCONQUEST 40 PTA DILATATION CATHETER
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V.
blvd montebello #1
parque industrial colonial
reynosa tamaulipas 88780
MX  88780
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe , AZ 85281
4803032689
MDR Report Key9596527
Report Number2020394-2020-00455
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 01/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/16/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberCQF7554
Device Catalogue NumberCQF7554
Device LOT NumberREDR4138
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/31/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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