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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 D134805
Device Problems Material Puncture/Hole (1504); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/02/2023
Event Type  malfunction  
Manufacturer Narrative
The product investigation was completed.Device evaluation details: visual analysis of the returned sample revealed a cut on pebax with reddish-brown material inside and internal parts exposed; however, the cut could be related to the handling since in the process there are control inspection points to avoid this kind of issue; however, this could not be conclusively determined.The magnetic and force feature was tested, and no errors were observed.The force values and the vector were observed within specifications.The blood found inside the pebax area may contribute to the force issue.A manufacturing record evaluation was performed for the finished device 31047143l number, and no internal action was found during the review.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.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 patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and post-procedure the bwi product analysis lab identified a cut on the pebax with internal parts exposed.During the procedure, a high force error was identified as ablation occurred.The catheter was replaced, the issue was resolved, and the procedure was continued.No patient consequences were reported.
 
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Brand Name
THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
Type of Device
CARDIAC ABLATION PERCUTANEOUS CATHETER
Manufacturer (Section D)
BIOSENSE WEBSTER INC
31 technology drive, suite 200
irvine CA 92618
Manufacturer (Section G)
BIOSENSE WEBSTER INC (JUAREZ)
circuito interior norte
1820parque industrial salvacar
juarez 32599
MX   32599
Manufacturer Contact
kate karberg
31 technology dr
irvine, CA 92618
3035526892
MDR Report Key17643672
MDR Text Key322198528
Report Number2029046-2023-01918
Device Sequence Number1
Product Code LPB
UDI-Device Identifier10846835010183
UDI-Public10846835010183
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P030031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 08/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberD134805
Device Lot Number31047143L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/24/2023
Initial Date Manufacturer Received 07/31/2023
Initial Date FDA Received08/29/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/04/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CARTO 3 SYSTEM
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