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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL TACTICATH QUARTZ; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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ST. JUDE MEDICAL TACTICATH QUARTZ; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION Back to Search Results
Model Number PN-004075
Device Problems Defective Device (2588); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/09/2015
Event Type  malfunction  
Event Description
The catheter was prepped and draped according to protocol.Catheter was plugged into the system, but the red light indicating error came on indication the catheter was not plugged in properly or there was an issue with the catheter.The reps did some troubleshooting and none of that worked so a new catheter from another lot number was used.The defective catheter was retained by the company rep.
 
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Brand Name
TACTICATH QUARTZ
Type of Device
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
Manufacturer (Section D)
ST. JUDE MEDICAL
5050 nathan lane
plymouth MN 55442
MDR Report Key5705939
MDR Text Key46821880
Report Number5705939
Device Sequence Number1
Product Code OAE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/14/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date08/25/2017
Device Model NumberPN-004075
Device Lot Number5135468
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2015
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/14/2015
Device Age3 MO
Event Location Hospital
Date Report to Manufacturer12/14/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/08/2016
Type of Device Usage N
Patient Sequence Number1
Treatment
NO
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