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

Catalog Number FG540000

Device Problem Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the investigational analysis has been completed.The biosense webster, inc.Field service engineer arrived on site for troubleshooting and repair.The system was started up, ecg tests (amplitude, limb, noise and pacing) and acl (raw current) were carried out, which ended satisfactorily and within the parameters specified by the manufacturer.The field service engineer tried to replicate the issue, simulating the configuration of equipment used during the procedure and no interference was observed in the generated ecg signal.The issue was not duplicated.System is operational.The device history record (dhr) review was performed by the manufacturer and no anomalies, which are related to the reported issue were noted in manufacturing or servicing of this equipment.Manufacturer's reference (b)(4).

Event Description

It was reported that a patient underwent an unknown procedure using the carto® 3 system and it was clarified that there was no ecg signal available to monitor the patient¿s heart rhythm.Initially, it was reported that when placing the radio frequency (rf) catheter, the readings were unstable, and noise was generated on the ecg.There was no patient consequence.With the information available, this event was assessed as not reportable as it was not reported that there were no ecg signals available to monitor the patient¿s heart rhythm.Therefore, the most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.Additional information was received on (b)(6) 2019 stating that the noise was observed on both the intracardiac electrogram (ic) and body surface (bs) signals.The noise spread to both the carto and the recording system.The noise also appeared on the anesthesia monitor, leaving the physician with no available ecg signal.This event was originally considered non-reportable, however, biosense webster, inc.Became aware that there was no ecg signal available to monitor the patient¿s heart rhythm on (b)(4) 2019 and per this additional information have reassessed the event as reportable.Therefore, the awareness date is reset to (b)(4) 2019.

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 8340473
• MDR Text Key: 139226813
• Report Number: 2029046-2019-02686
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000
• Date Manufacturer Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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