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U.S. Department of Health and Human Services

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

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BIOSENSE WEBSTER INC CARTO 3 SYSTEM (FOR JAPAN); COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
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).
 
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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 Key18143014
MDR Text Key328196866
Report Number2029046-2023-02656
Device Sequence Number1
Product Code DQK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K042999
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberFG540000J
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/20/2023
Initial Date FDA Received11/15/2023
Supplement Dates Manufacturer Received11/29/2023
Supplement Dates FDA Received12/18/2023
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 Number1
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 Age68 YR
Patient Weight63 KG
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