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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER

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BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Catalog Number UNK_SMART TOUCH BIDIRECTIONAL
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Heart Block (4444)
Event Date 02/17/2021
Event Type  Injury  
Manufacturer Narrative
Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed. Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer. If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda. Manufacturer's reference number: (b)(4).
 
Event Description
It was reported that a (b)(6) old female patient ((b)(6) kg) with a history of congenital heart defect, single ventricle s/p glenn (cardiac surgery) underwent a atrioventricular reentrant tachycardia (avrt) and wolff-parkinson-white (wpw) with an unspecified thermocool® smart touch® sf bi-directional navigation catheter and experienced heart block. During the ablation when radiofrequency (rf) is on, the back patch displays a back patch detached error. Patch placement is limited based on patient size. The patches and cables seem to be isolated from each other and the indifferent electrode is on the right leg. A second indifferent electrode was added without resolution. The patches were replaced. The back- patch sensor cable was replaced, and the carto 3 system was rebooted. The caller stated that the replacement patch sensor cable was difficult to seat in the patch unit then a 1006 error displayed after the cable replacement. The original sensor cable was connected back to the piu/patch unit and the 1006 resolved. After 11 seconds of rf a small steam pop occurred then 2:1 heart block which resolved within a few minutes. A back patch 3 disconnect error was then displayed on the carto 3. The outcome of the adverse event: fully recovered no adverse events noted. Since the event is life-threatening and required intervention to prevent permanent impairment of a body function or permanent damage to a body structure, then it is to be considered serious and mdr-reportable.
 
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Brand NameTHERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
Type of DeviceCARDIAC ABLATION PERCUTANEOUS CATHETER
Manufacturer (Section D)
BIOSENSE WEBSTER INC
33 technology drive
irvine CA 92618
Manufacturer (Section G)
BIOSENSE WEBSTER INC (JUAREZ)
circuito interior norte
1820parque industrial salvacar
juarez 32599
MX 32599
Manufacturer Contact
gabriel alfageme
31 technology dr
irvine, CA 92618
9497898687
MDR Report Key11449117
MDR Text Key239828365
Report Number2029046-2021-00327
Device Sequence Number1
Product Code LYB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK_SMART TOUCH BIDIRECTIONAL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/09/2021 Patient Sequence Number: 1
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