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

Model Number D134805

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

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

Event Date 05/03/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a bad/no ecg on all channels issue occurred.It was reported that the carto 3 system displayed an error 7, "current leakage error," when the ablation catheter was connected to the piu.When the current leakage error came up, there was no ecg signal.The catheter was in the body; however, it was then taken out.They tried unplugging everything from the piu and restarting it as well as with a brand-new cable and this did not resolve the issue.When the catheter was replaced, the issue was resolved, and the procedure was continued.No adverse patient consequence was reported.The current/leakage device disruption is not mdr reportable.This issue is highly detectable and requires adjusting system components to continue with the procedure.Devices may require reset or replacing but cannot be used on the patient.Patient safety is unaffected by this issue.The bad/no ecg signal on all channels is mdr reportable.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The device evaluation was completed on 20-jun-2023.It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and a bad/no ecg on all channels issue occurred.It was reported that the carto 3 system displayed an error 7, "current leakage error," when the ablation catheter was connected to the piu.When the current leakage error came up, there was no ecg signal.The catheter was in the body; however, it was then taken out.They tried unplugging everything from the piu and restarting it as well as with a brand-new cable and this did not resolve the issue.When the catheter was replaced, the issue was resolved, and the procedure was continued.No adverse patient consequence was reported.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, electrical, magnetic sensor functionality, and cool flow pump test of the returned device were performed following bwi procedures.Visual analysis revealed no damage on the device; however, moisture was observed in the connector coupler.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly; no magnetic issues or current leakage errors were observed.A cool flow pump test was performed, and the device was irrigating correctly.No irrigation issues were observed.An electrical test was performed, and no electrical issues were found.The corrosion observed in the connector could be caused by a leak during the procedure and directly related to the issues described by the customer; however, this cannot be conclusively determined.The root cause of corrosion cannot be determined since there was no water leakage observed during cool flow pump test.A manufacturing record evaluation was performed for the finished device number lot 31012980l and no internal actions related to the complaint were found during the review.The issues reported by the customer were confirmed.It should be noted that product failure is multifactorial.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.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® 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 Key: 17028789
• MDR Text Key: 317493967
• Report Number: 2029046-2023-01181
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

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 Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 31012980L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/31/2023
• Supplement Dates Manufacturer Received: 06/20/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: THMCL SMTCH SF BID, TC, D-F.; UNK BRAND CABLE.; UNK BRAND CABLE.; UNK_CARTO 3.