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

Model Number FG540000

Device Problem Fire (1245)

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 atrial fibrillation (afib) ablation procedure with a carto® 3 system.The spu was overheating.It was reported that while using the pentaray the spu was overheating.They disconnected it.After the case, they rebooted the patient interface unit (piu) and after the reboot, they connected the spu and the spu was overheating again and there was a burning smell.The spu serial # (b)(4).An error appeared and said spu temperature reading is out of range.And to not touch the spu, it may cause burn.Bwi sales consultant does not remember the error number.The bwi company representative did not see any smoke.The bwi company representative immediately unplugged the power source to the spu and turned it off.At the end of the case, they rebooted the piu and spu.Again, the temperature error popped up and the spu was red, and they could smell the burning smell again.They immediately unplugged the power source to the spu again and then called it in to tech services.The procedure and the alert date both occurred on friday, (b)(6) 2022.No patient consequences were reported.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 atrial fibrillation (afib) ablation procedure with a carto® 3 system.The spu was overheating.Device evaluation details: the issue was confirmed.Found burning smell and overheating on snippet processing unit (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 send 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.For more info, please see attachments in this event.Due to the condition of the spu, 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).

• 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: 15359787
• MDR Text Key: 299261090
• Report Number: 2029046-2022-02116
• 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: 12/14/2022

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?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1