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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD CONQUEST PTA BALLOON DILATATION CATHETER

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BARD CONQUEST PTA BALLOON DILATATION CATHETER Back to Search Results
Model Number CQ7584
Device Problems Material Separation (1562); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/01/2017
Event Type  malfunction  
Event Description
The pt underwent a fistulogram and balloon angioplasty of the venous anastomosis and axillary vein. The outside layer of the angioplasty balloon started coming apart.
 
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Brand NameCONQUEST
Type of DevicePTA BALLOON DILATATION CATHETER
Manufacturer (Section D)
BARD
MDR Report Key7049093
MDR Text Key92746969
Report NumberMW5073470
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 11/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Model NumberCQ7584
Device Catalogue NumberCQ7584
Device Lot NumberREBU1050
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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