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

Catalog Number	D132704
Medical Device Problem Codes	Electrical Shorting (2926); Appropriate Device Problem Term/Code Not Available (3191); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Biosense webster manufacturer's reference number pc-001579344 has two reports: (1) mfr # 2029046-2024-01394 for product code d132704 (thermocool® smart touch¿ bi-directional navigation catheter) (2) mfr # 2029046-2024-01393 for product code fg540000 (carto® 3 system).
Event or Problem Description
It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation which included a thermocool® smart touch¿ bi-directional navigation catheter and a carto® 3 system and the patient experienced electrical shock.It was reported that the patient got electrocuted right when the physician was about to put the catheter in the groin.The physician stated that there was water on the groin.The patient screamed after receiving the electric shock and a current leakage error 7 appeared on the carto 3 system.The patient stated that there was a shock in her leg.The catheter was not fully connected to the handle of the catheter.The physician pulled the catheter back and gave the patient a chance to recover.The last known patient status was that the patient was stable and awake.The procedure continued.The account was advised to stop using the carto 3 system.Additional information received indicated that the physician believed that it was due to his fellow connecting the catheter incorrectly.The cable was not completely seated into the handle of the catheter at the time of the event.There was an optrell and soundstar in the body.However, the event occurred just as the physician brought the ablation catheter to the groin.The patient was back to normal within minutes and fully recovered.The patient did not require extended hospitalization.Other relevant history noted that this is the patient¿s 5th time coming in for a premature ventricular contractions (pvc) ablation.Since there was no indication that the electrical shock has contributed to any permanent impairment and/or damage to the patient, no medical or surgical intervention was necessary, no extended hospitalization was reported, and no indication that this event was life threatening, this event does not meet the criteria for reporting to the us fda.However, this complaint is still mdr reportable as a malfunction.If further information is received, the patient event reportability will be re-assessed.
Additional Manufacturer Narrative
It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation which included a thermocool® smart touch¿ bi-directional navigation catheter and a carto® 3 system and the patient experienced electrical shock.It was reported that the patient got electrocuted right when the physician was about to put the catheter in the groin.The physician stated that there was water on the groin.The patient screamed after receiving the electric shock and a current leakage error 7 appeared on the carto 3 system.The patient stated that there was a shock in her leg.The catheter was not fully connected to the handle of the catheter.The physician pulled the catheter back and gave the patient a chance to recover.The last known patient status was that the patient was stable and awake.The procedure continued.The account was advised to stop using the carto 3 system.Additional information received indicated that the physician believed that it was due to his fellow connecting the catheter incorrectly.The cable was not completely seated into the handle of the catheter at the time of the event.There was an optrell and soundstar in the body.However, the event occurred just as the physician brought the ablation catheter to the groin.The patient was back to normal within minutes and fully recovered.The patient did not require extended hospitalization.Other relevant history noted that this is the patient¿s 5th time coming in for a premature ventricular contractions (pvc) ablation.Since there was no indication that the electrical shock has contributed to any permanent impairment and/or damage to the patient, no medical or surgical intervention was necessary, no extended hospitalization was reported, and no indication that this event was life threatening, this event does not meet the criteria for reporting to the us fda.However, this complaint is still mdr reportable as a malfunction.If further information is received, the patient event reportability will be re-assessed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection, electrical and magnetic sensor functionality test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly.No magnetic issues or current leakage were observed.The device was connected to the electrical test box to measure the resistance of the electrodes, and all values were found within specifications.No current leakage or other electrical issues were found.Finally, a review of the insulation of the electrical printed circuit board was performed and no anomalies were found.No failures were found in the electrical insulation.The electrical issues reported by the customer could not be replicated during the product investigation.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.The potential cause of the electrical shock could be related to the procedure, since the customer referenced that there was water on the groin; however, this cannot be conclusively determined.The instructions for use contain the following warning and precaution: before use, the catheter must be warmed up as specified in the ¿directions for use¿ section of the ifu document.Do not immerse the handle or cable connector in fluids; electrical performance could be affected.Read and follow the indifferent electrode manufacturer¿s instructions for use.In relation to, the current leak issue, the carto® 3 system instructions for use contain the following information: disconnect all catheter cables from the piu.If the error persists after disconnecting all catheter cables from the piu, turn off the piu power supply and contact biosense webster service and support department to report a piu issue.If the error message disappears after disconnecting all catheter cables, reconnect the catheter cables, one by one, until the catheter or cable causing the error is identified.Replace the faulty catheter and/or cable.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2024-01394 for product code d132704 (thermocool® smart touch¿ bi-directional navigation catheter).(2) mfr # 2029046-2024-01393 for product code fg540000 (carto® 3 system).

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: 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: 19206926
• Report Number: 2029046-2024-01394
• Device Sequence Number: 20845229
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: 10846835009194
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/05/2026
• Device Catalogue Number: D132704
• Device Lot Number: 31033171M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM.; UNK_CORONARY SINUS CATHETER.; UNK_OPTRELL MAPPING CATHETER.; UNK_SOUNDSTAR ECO.
• Patient Age: 23 YR
• Patient Sex: Female