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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 D134804
Device Problem Failure to Sense (1559)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/26/2023
Event Type  malfunction  
Event Description
It was reported that a patient underwent a atrioventricular nodal reentrant tachycardia (avnrt) procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a cut on the pebax and internal parts exposed.Initially it was reported that the carto 3 system displayed a force sensor error (error code 106) when the catheter was connected to the patient interface unit (piu).They reseated the catheter but the issue persisted.The cable was replaced without resolution.The catheter was replaced and the issue was resolved.The procedure was continued.No patient consequence reported.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on (b)(6) 2023, there was a cut on the pebax with reddish-brown material inside and internal parts exposed.This event was originally considered non-reportable, however, bwi became aware of a cut on the pebax and internal parts exposed on (b)(6) 2023 and have assessed this returned condition as reportable.
 
Manufacturer Narrative
The device evaluation was completed on (b)(6) 2023.The device was returned to biosense webster (bwi) for evaluation.Visual inspection, and screening tests of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed a cut on the 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.Then the device was connected to the carto 3 system, and the device was visualized and recognized correctly; however, error 106 appeared on the system due to an open circuit on the tip area.A manufacturing record evaluation was performed for the finished device, and no internal action was found during the review.The force issue reported by the customer was confirmed; however, the reddish material is not related to the customer complaint.The instructions for use (ifu) contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sleeve (g04115) were selected as related to the biosense webster inc.Analysis finding of the ¿cut on the pebax with reddish-brown material inside and internal parts exposed¿.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to the customer¿s reported ¿force sensor error (error code 106)¿.Manufacturer's reference number: (b)(4).
 
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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 Key18315671
MDR Text Key330943608
Report Number2029046-2023-02934
Device Sequence Number1
Product Code LPB
UDI-Device Identifier10846835010176
UDI-Public10846835010176
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,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 12/12/2023
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 NumberD134804
Device Lot Number31080515L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2023
Initial Date Manufacturer Received 11/15/2023
Initial Date FDA Received12/12/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2023
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
UNK CABLE; UNK_CARTO 3
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