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

Catalog Number FG540000

Device Problems Device Emits Odor (1425); Patient Device Interaction Problem (4001)

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

Event Date 07/12/2023

Event Type  Injury  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.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.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

It was reported that a patient underwent an idiopathic ventricular tachycardia procedure (idvt) ablation procedure with a carto 3 system.It was reported that the carto 3 system did not recognize the location pad.The system was rebooted then displayed a current leakage error.The system would not reset the current leakage error.The carto 3 system was rebooted again, then there was a strong smell of electrical burning coming from the patient interface unit (piu).The system booted up with the following errors: 42 20 pole a: defective catheter or cable.43 20 pole b: defective catheter or cable.7, current leakage and the mag card had a red light on the back of the piu.Carto 3 sw version 7.5.1.327.Case cancelled.It was confirmed that the "current leakage error" was accompanied by a signal noise / signal loss issue.The signal interference (noise/loss )was observed on all body surface (bs) and intracardiac (ic).The signal interference (noise/loss) was observed on both carto® and recording system.There was an electrocardiogram (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.None of the catheters showed up on carto catheter screen.Not even the ultra sound dongle.Carto did not recognize that any catheters or cables were connected to the piu.Patient was in the room at the time of the cancellation.Patient was under general anesthesia for 30 minutes.Transseptal puncture was not performed prior to the case cancellation.In the physician¿s opinion, cancelation of the procedure did not contribute to a death or a serious injury to the patient.Patient required extended hospitalization due to a medical condition caused by procedure cancellation as patient stayed an extra night and had the procedure completed the next day.Clinician note: although multiple error codes were indicated, the details of the event point to the piu as the source of the device malfunction--there was a burning smell from the piu itself.Additional information: there was no visible smoke.The aroma was like burnt electrical wires or components.That smell was coming from the front of the piu.It was a strong enough scent that they all stopped what they were doing to find the source.The medical team could smell it even with their masks on.No or electrical issues external to the piu were involved to my knowledge.Upon inspection, the location pad card had some visible burned/ blackened spots on some of the circuits.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious.

Manufacturer Narrative

On 20-dec-2023, the product investigation was completed.It was reported that a patient underwent an idiopathic ventricular tachycardia procedure (idvt) ablation procedure with a carto 3 system.It was reported that the carto 3 system did not recognize the location pad.The system was rebooted then displayed a current leakage error.The system would not reset the current leakage error.The carto 3 system was rebooted again, then there was a strong smell of electrical burning coming from the patient interface unit (piu).The system booted up with the following errors: 42 20 pole a: defective catheter or cable.43 20 pole b: defective catheter or cable.7, current leakage and the mag card had a red light on the back of the piu.It was confirmed that the "current leakage error" was accompanied by a signal noise / signal loss issue.The signal interference (noise/loss )was observed on all body surface (bs) and intracardiac (ic).The signal interference (noise/loss) was observed on both carto® and recording system.There was an electrocardiogram (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.None of the catheters showed up on carto catheter screen.Not even the ultra sound dongle.Carto did not recognize that any catheters or cables were connected to the piu.Patient was in the room at the time of the cancellation.Patient was under general anesthesia for 30 minutes.Transseptal puncture was not performed prior to the case cancellation.In the physician¿s opinion, cancelation of the procedure did not contribute to a death or a serious injury to the patient.Patient required extended hospitalization due to a medical condition caused by procedure cancellation as patient stayed an extra night and had the procedure completed the next day.Device evaluation details: the field service engineer confirmed that the issue was resolved by replacing the lp/mag tx kit with another one that was delivered to the customer.The suspected lp/mag tx kit was sent to the manufacturer for investigation.It was found that the location pad cable was physically damaged.The cable was repaired and the issue resolved.No evidence of burning smell was found from the mag tx.In addition, the field service engineer replaced the backplane card due to damaged connectors.The backplane card was not sent to the manufacturer for investigation because it was scrapped.The system is ready for use.The manufacturing record evaluation was performed on carto 3 system #11185, and no internal actions related to the reported complaint condition were identified.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: 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: 17492338
• MDR Text Key: 320732557
• Report Number: 2029046-2023-01729
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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?: No
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: THERMOCOOL SMARTTOUCH
• Patient Outcome(s): Hospitalization