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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053

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BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER SIMILAR DEVICE D133601, PMA # P030031/S053 Back to Search Results
Catalog Number D133605IL
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2021
Event Type  malfunction  
Manufacturer Narrative
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. (b)(4).
 
Event Description
It was reported that an unknown patient underwent an atrial tachycardia (at) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter. Foreign material found inside the pebax. It was reported that error code 84,86,87,88 displayed during the la mapping. Physician switched the connector cables, but the problem couldn't be resolved. Then physician removed the catheter for checking and found foreign material such as blood inside the pebax. The integrity of the pebax sleeve has not been compromised (no openings are present that would allow fluid or components enter or exit the sleeve area). Physician switched another new catheter to complete the procedure. No injury was reported. Foreign material inside of the pebax is mdr-reportable.
 
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Brand NameTHERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER
Type of DeviceSIMILAR DEVICE D133601, PMA # P030031/S053
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 Key11622985
MDR Text Key246297103
Report Number2029046-2021-00521
Device Sequence Number1
Product Code LYB
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberD133605IL
Device Lot Number30482199M
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/06/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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