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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER

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BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER Back to Search Results
Catalog Number D134722IL
Device Problem Signal Artifact/Noise (1036)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2021
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 electrical evaluation of the returned device. Visual analysis of the returned sample revealed that the catheter was inspected and it was found that an electrode was damaged. Sharp edges were observed due to lifted electrode was observed on the stsf. This issue could have happened due to excessive force or manipulation, however, this cannot be conclusively determined. An electrical test was performed on the catheter and it was found within specifications. No electrical malfunction was observed. A manufacturing record evaluation was performed for the finished device 30483439l number, and no internal action was found during the review. As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications. Although no electrical issue could be reach on the cause of the reported event. To minimize ecg noise, the following guidelines should be followed. Ecg noise is typically generated as the result of improper connection of the body surface ecg patch to the patient. This noise is the most significant during ablation. To resolve this situation, verify proper connection. It is recommended to turn off the notch filter for this verification. The event described could not be confirmed as the as the device performed without any electrical issues. Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis. 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 atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® catheter for which biosense webster¿s product analysis lab identified a damaged/lifted electrode resulting in exposed sharp edges. During the procedure, signal interference noise was observed on ic, bs, and ecg channels. A second catheter was used to complete the operation. No patient consequences were reported. The noise issue is not mdr-reportable. The damaged electrode and sharp edges are mdr-reportable.
 
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Brand NameTHERMOCOOL SMART TOUCH 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 Key12037129
MDR Text Key263531624
Report Number2029046-2021-00959
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 06/02/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberD134722IL
Device Lot Number30483439L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/04/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/16/2020
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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