MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133604IL

Device Problems Communication or Transmission Problem (2896); Electrical Shorting (2926)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2023

Event Type  malfunction  

Manufacturer Narrative

The product has not returned for analysis, however, a picture was provided by the customer.Evaluation is still in progress.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The ¿suspected medical device¿ reported in section d of this report is not marketed in usa or approved by the fda.However, it is being reported as biosense webster considers this as a similar device to thermocool® smart touch¿ electrophysiology catheter approved under pma # p030031/s053.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and an issue with no ecg on all channels occurred.It was reported that there was a current leakage-device disruption.It was reported that during procedure, leakage current was detected on piu rl input.A second device was used to complete the operation.There was no adverse event reported on patient.The signal interference (noise/loss) was observed on all ecg (bs + ic) channels, carto® and recording system.There was no ecg/ekg signal available for the physician to monitor the patient¿s heart rhythm.During the signal interference/loss, the affected catheter was inside the patient¿s body.Product is unavailable to return due to infectious disease.The issue with bad/no ecg on all channels was assessed as mdr reportable.

Manufacturer Narrative

The photo evaluation was completed on 01-feb-2023.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and an issue with no ecg on all channels occurred.Photo evaluation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, leakage current has been detected, message was observed on the carto 3 screen.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the reported complaint were identified.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.H6.Investigation findings code of "appropriate term/code not available" represents photo/video 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).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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 Key: 16276165
• MDR Text Key: 308530034
• Report Number: 2029046-2023-00196
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2023
• Device Catalogue Number: D133604IL
• Device Lot Number: 30771543M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: THMCL SMARTTOUCH,TC,D,C3,OBL