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U.S. Department of Health and Human Services

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

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BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Catalog Number D134721IL
Device Problems Material Puncture/Hole (1504); Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/10/2023
Event Type  malfunction  
Manufacturer Narrative
The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection and deflection test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed reddish material inside pebax due to a hole in the pebax of the catheter.The root cause of the damage on the pebax, it was concluded that it occurred outside the bwi manufacturing facilities.A deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.The deflection issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.A manufacturing record evaluation was performed for the finished device number lot 31033754l, and no internal actions related to the complaint were found during the review.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 an unspecified ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and post-procedure the bwi product analysis lab identified a hole in the pebax.During the operation, catheter was unable to deflect or relax completely.A second device was used to complete the operation.There was no adverse event reported on patient.The deflection issue is not mdr-reportable.The hole in the pebax is mdr-reportable.
 
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Brand Name
THERMOCOOL® SMART TOUCH® SF UNI-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 Key17895583
MDR Text Key325258341
Report Number2029046-2023-02257
Device Sequence Number1
Product Code LPB
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P030031/S053
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 10/09/2023
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 Expiration Date04/11/2024
Device Catalogue NumberD134721IL
Device Lot Number31033754L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2023
Initial Date Manufacturer Received 09/11/2023
Initial Date FDA Received10/09/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/12/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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