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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER BIOSENSE WEBSTER PENTARAY CATHETER

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BIOSENSE WEBSTER BIOSENSE WEBSTER PENTARAY CATHETER Back to Search Results
Catalog Number D128210
Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Remove (1528)
Patient Problem No Code Available (3191)
Event Date 12/12/2016
Event Type  Injury  
Event Description

Patient s/p and fibrillation ablation yesterday. During procedure, pentaray catheter was caught and broke off in mechanical mitral valve, leaving leaflet closed. One functional leaflet. Patient had emergent heart cath in the case of patient requiring emergent surgery for valve. Coronaries patent. Patient stable, denies pain, shortness of breath.

 
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Brand NameBIOSENSE WEBSTER
Type of DevicePENTARAY CATHETER
Manufacturer (Section D)
BIOSENSE WEBSTER
phoenix AZ 85016
MDR Report Key6185344
MDR Text Key62842341
Report NumberMW5066743
Device Sequence Number1
Product Code MTD
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 12/13/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/13/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2016
Device Catalogue NumberD128210
Device LOT Number17564900L
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? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/13/2016 Patient Sequence Number: 1
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