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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 D133605IL
Device Problems Material Puncture/Hole (1504); Application Program Problem (2880)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2021
Event Type  malfunction  
Manufacturer Narrative
The product investigation was completed. Device evaluation details: the product was returned to biosense webster for evaluation. Bwi conducted a visual inspection and magnetic evaluation of the returned device. Visual analysis of the returned sample revealed that reddish material and a hole in the pebax were observed on the smart touch unidirectional catheter. Magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed. The evaluation determined that the cause of pebax damage failure cannot be established. The event described magnetic distortion was unable to duplicate during the product investigation. However, the blood found inside the pebax area may contributed to the unable to map reported. A manufacturing record evaluation was performed for the finished device [30471946m] number, and no internal actions related to the reported complaint condition were identified. The instructions for use contain the following warning stated in the carto 3 system manual: the magnetic sensor of the catheter is disconnected. If the problem persists, replace the catheter cable or the catheter. Regarding the additional finding observed, the instruction for use contains the following information: in order to prevent damage to the catheter tip, use the insertion tube supplied with the catheter to advance or retract the catheter through the hemostasis valve of the sheath. 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
A patient underwent an ablation atrial fibrillation (afib) procedure with a thermocool¿ smart touch¿ sf bi-directional navigation catheter for which biosense websters product analysis lab identified reddish material and a hole in the pebax. During the procedure, a error 401 was displayed on the carto system. The catheter was replaced and the issue resolved. There was no adverse event or patient consequences reported on the patient. The error 401 (mapping error) is not mdr-reportable. The hole in the pebax is 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
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
gabriel alfageme
31 technology dr
irvine, CA 92618
9497898687
MDR Report Key12014662
MDR Text Key256759207
Report Number2029046-2021-00945
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
Report Date 05/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberD133605IL
Device Lot Number30471946M
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/17/2021 Patient Sequence Number: 1
Treatment
CARTO 3 SYSTEM
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