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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL SMARTTOUCH BIDIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

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BIOSENSE WEBSTER INC. THERMOCOOL SMARTTOUCH BIDIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Model Number D134805
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2022
Event Type  malfunction  
Event Description
Ablation catheter not working.
 
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Brand Name
THERMOCOOL SMARTTOUCH BIDIRECTIONAL NAVIGATION CATHETER
Type of Device
CARDIAC ABLATION PERCUTANEOUS CATHETER
Manufacturer (Section D)
BIOSENSE WEBSTER INC.
MDR Report Key15987562
MDR Text Key305684756
Report NumberMW5113806
Device Sequence Number1
Product Code LPB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberD134805
Device Catalogue NumberD134805
Device Lot Number30902771L
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
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