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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 CQF75108
Device Problems Break; Material Puncture / Hole; Retraction Problem
Event Type  Malfunction  
Manufacturer Narrative

The lot number for the malfunction was provided and a lot history review was performed. The device has been returned for evaluation; the investigation is confirmed for a break in the shaft; however, the investigation is inconclusive for the reported retraction issues as the device was unable to be functionally tested due to the break in the shaft. Based upon the available information, the definitive root cause is unknown. The device is labeled for single use.

 
Event Description

This report summarizes one malfunction. A review of the reported information indicated that model cqf75108 pta balloon dilatation catheter allegedly experienced a break, material puncture, and a retraction problem. This information was received from a single source. The malfunction involved a patient with no reported consequence. The patient¿s age, weight, and sex were not provided.

 
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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
1625 w 3rd st.
tempe , AZ 85281
4803032689
MDR Report Key8796346
Report Number2020394-2019-01538
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 07/16/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/16/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberCQF75108
Device Catalogue NumberCQF75108
Device LOT NumberRECX1232
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 Received06/30/2019
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 Initial

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