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

Model Number FG540000

Device Problems Signal Artifact/Noise (1036); Electrical Shorting (2926); Appropriate Term/Code Not Available (3191)

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

Event Date 07/01/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial flutter ablation procedure with a carto® 3 system and an ecg issue, no signal on carto and no external signal occurred.It was reported that a current leakage error message occurred.They tried to change different electrodes, restarted the piu only, but they did not solve the issue.They also had bad and noisy signal on the pentaray, ecg and cs catheter when they connected the mapping catheter.They tried to change the mapping catheter with a new one; however, it did not solve the issue.They did map only with the pentaray but still had noisy and bad signal on the pentaray, ecg and cs catheter.Then, the system did not allow them to ablate.They had cautions/warnings.They tried to change the catheter three times with new ones; however, it did not solve the issue this issue has not been solved and the case was cancelled.There was a one-hour delay.No patient consequences were reported.Additional information was received on 15-aug-2022.The patient was not under general or local anesthesia.A transseptal puncture was not performed prior to the case cancellation.In the physician¿s opinion, the cancelation of the procedure did not contribute to a serious injury to the patient.It is unknown if the patient required extended hospitalization due to a medical condition caused by procedure cancellation.The signal interference (noise) was observed on all ecg (bs + ic) channels.The signal interference (noise) was observed on carto® and recording system.The physician did not have any intact ecg signal available to monitor patient heart rhythm (example: body surface, anesthesia monitor, defibrillator).During the signal interference, the catheter was inside the patient¿s body.There wasn't an affected catheter.The current leakage issue was assessed as 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 ecg issue, no signal on carto and no external signal was assessed as a mdr reportable product malfunction.

Manufacturer Narrative

The bwi field service engineer (fse) performed preventative maintenance testing and confirmed that the system was working fine with no current leakage and no noise.It was confirmed to be a non-carto issue.The history of customer complaints reported during the last year associated with carto 3 system # 11652 was reviewed.No similar complaints were found.A manufacturing record evaluation was performed for the carto 3 system # 11652, and no internal actions related to the reported complaint condition were identified.(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 4.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

Per the manufacturing record evaluation, the h4.Device manufacture date was updated and a manufacture date of 08-dec-2010 was added.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15404019
• MDR Text Key: 306164926
• Report Number: 2029046-2022-02200
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG540000
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2010
• 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: SMARTABLATE GENERATOR KIT-WW; UNK BRAND CATHETER; UNK BRAND CATHETER; UNK BRAND CATHETER; UNK_PENTARAY