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

Catalog Number FG540000J

Device Problems Electrical /Electronic Property Problem (1198); Patient Device Interaction Problem (4001)

Patient Problem Atrial Fibrillation (1729)

Event Date 10/20/2023

Event Type  Injury  

Event Description

It was reported that a patient planned to undergo an atrial fibrillation ablation procedure using carto and back patches.The patient procedure was incomplete due to product issues.A 1006 backpatch sensor error occurred.The medical team checked the patch and it was shaded.The cord routing was reviewed and adjusted but the issue continued.The team then restarted patient interface unit (piu) and re-entered study (the patient information and parameters to start the mapping process), but it was completely unresponsive.The medical team then arranged for a backup piu with the agency (30 minutes after arrival) and also discussed with called a field service engineer.The procedure was not able to be completed before the backup arrived, and the physician was angry.After the procedure, the backup piu confirmed that there was no problem.In the opinion of the physician, the delay did not contribute to a serious injury or death towards the patient.The patient was in af (atrial fibrillation) when he entered the room and was defibrillated during the procedure.The patient condition after the procedure was unknown, but the patient was in need of further treatment at a later date.Although in the opinion of the physician, the delay did not contribute to a serious injury or death towards the patient, intervention (defibrillation) was needed due to the delay in the procedure and thus puts the patient at an increased risk, making this fda reportable.

Manufacturer Narrative

E1 initial reporter phone: (b)(6).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).

Manufacturer Narrative

On 29-nov-2023, bwi received additional information regarding the event.The procedure was completed without patient's consequence and although the original information reports that "the patient was in need of further treatment at a later date".The new information received indicates that the patient may not need another ablation in the future and a holter/ecg (electrocardiogram) was to be done at the one month follow up.Cardioversion (referred to as defibrillation) is commonly used to treat atrial fibrillation and the patient was in atrial fibrillation when he entered the room, thus disassociating the delay with the arrhythmia.Also in the opinion of the physician, the delay did not contribute to a serious injury or death towards the patient.As a result, there is no reportable adverse event that was inflicted upon the patient.This event is not fda-reportable.No further reports shall be submitted regarding this event.Manufacturer's reference number: (b)(4).

• Brand Name: CARTO 3 SYSTEM (FOR JAPAN)
• 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: 18143014
• MDR Text Key: 328196866
• Report Number: 2029046-2023-02656
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042999
• 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
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: FG540000J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 8.5F SHEATH WITH CURVE VIZ MDC; CARTO 3 SYSTEM (FOR JAPAN); CARTO3 EXTERNAL REFPATCH 6PACK; OCTA,LNG,48P,3-3-3-3-3,D-CURVE; SMARTABLATE IRR TUBE SET; SOUNDSTAR ECO SMS 8F CATHETER; THMCL SMTCH SF BID, TC, D-F
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 63 KG