MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO® 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Catalog Number FG540000

Device Problems Electrical Shorting (2926); Appropriate Term/Code Not Available (3191); Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 04/03/2024

Event Type  malfunction  

Event 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.

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 (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: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19208895
• MDR Text Key: 341732119
• Report Number: 2029046-2024-01393
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: THMCL SMRTTCH,BI,NAV,TC,F-J,C3.; UNK_CORONARY SINUS CATHETER.; UNK_OPTRELL MAPPING CATHETER.; UNK_SOUNDSTAR ECO.
• Patient Age: 23 YR
• Patient Sex: Female