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

Model Number FG540000

Device Problems Fire (1245); Device Emits Odor (1425); Communication or Transmission Problem (2896)

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

Event Date 08/12/2022

Event Type  malfunction  

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 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.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 an unknown patient underwent an pulmonary vein isolation (pvi) ablation procedure with a carto® 3 system.There was a burning smell coming from snippet processing unit (spu) while powered.No patient consequences were reported.Field service engineer noted the following in the carto 3 system: 984: spu version mismatch error (like on friday); 993: spu: power card sensor reading is out of range; 987: spu: temperature reading is out of range.Cas noticed a "burning smell" coming from the spu while powered.Communication issue/error is not mdr-reportable.Fire hazard is mdr-reportable.

Manufacturer Narrative

On 6-dec-2022, the product investigation was completed.It was reported that an unknown patient underwent an pulmonary vein isolation (pvi) ablation procedure with a carto® 3 system.There was a burning smell coming from snippet processing unit (spu) while powered.No patient consequences were reported.Device evaluation details: it was confirmed that the issue was resolved by replacing the faulty spu with another one that was delivered to the customer.The issue was resolved.Replaced spu was sent at htc for investigation and repair.Spu s433997 was investigated in device manufacturer & sanmina.The issue was confirmed.Found burning smell and overheating on spu power card.Also found errors in aquarium test and spu internal bit tests failed.Replacing of u9 in spu power card ea-5070-16f solved the reported issue.Finally it was decided to sent power card to scrap and replace it with new card.Also replace ecg card (ea-5070-18f) and upgrade digital (ea-5070-17f).Spu retest all tests.Since an spu-related issue was identified, an internal action was opened.A manufacturing record evaluation was performed for the system #(b)(6), 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) per internal review, it was identified that the h8 usage of device was mistakenly indicated as "initial use of device".That is incorrect.The h8 field has been updated to "reuse" since the carto 3 system is reusable hardware.

• 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: 15366873
• MDR Text Key: 299351417
• Report Number: 2029046-2022-02125
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• 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?: Yes
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/30/2014
• 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