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

Model Number FG540000

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.Additionally, if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(6).(b)(4).

Event Description

It was reported that male patient underwent a left atrial flutter ablation procedure with a carto® 3 system and a ¿current leakage¿ error was displayed during use.Actions taken included first catheter kit (materials) replacements and the carto® 3 system worked fine for a while but afterwards the problem persisted.The carto® 3 system has been reset a few times, but nothing happened.Therefore, the caller did not know if the problem was material or the carto® 3 system.To preserve patient safety, the physician was encouraged to discontinue the procedure as the patient had been under general anesthesia for 3 hours.Patient reportedly fully recovered with no residual effects and there was no other patient consequence.The patient was to be rescheduled to do another ablation procedure.The ¿current leakage error¿ was not displayed due to a noise issue.Transseptal puncture had been performed prior to the procedure cancellation.In the opinion of the physician, this certainly presented risk of injury because the doctor was not able to finalize the ablation.The procedure was canceled in middle due to this issue.The physician chose to stop the mapping and ablation was not performed.The patient had no treatment for his arrhythmia and will have to come back to the hospital to do another procedure.No extended hospitalization was required.The cause of the event was bwi product malfunction.Since it was stated by the caller that the catheters/materials were replaced without resolution, it¿s been determined that the error was caused by a problem with carto® 3 system itself, therefore, the procedure cancellation issue will be conservatively reported under the carto® 3 system.

Manufacturer Narrative

On 1/6/2020, biosense webster inc.Received additional information was presented to clarify that the catheter kit is in reference to replacing the connector first and then the catheter.Yes, this was indeed a transseptal catheterization procedure.It was indicated that the needle was being used with the preface sheath and the procedure was discontinued because the doctor wanted to preserve the patient.Additionally, the date of manufacture was received as 4/30/2014.Field h4.Device manufacture date has been populated.Manufacturer¿s ref # (b)(4).

Manufacturer Narrative

On 3/19/2020, additional information was received providing product details for an additional concomitant product used during this procedure.The product has been added the field d11.Concomitant med.Product.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref # pc-(b)(4).

Manufacturer Narrative

It was reported that male patient underwent a left atrial flutter ablation procedure with a carto® 3 system and a ¿current leakage¿ error was displayed during use.Actions taken included first catheter kit (materials) replacements and the carto® 3 system worked fine for a while but afterwards the problem persisted.The carto® 3 system has been reset a few times, but nothing happened.Therefore, the caller did not know if the problem was material or the carto® 3 system.To preserve patient safety, the physician was encouraged to discontinue the procedure as the patient had been under general anesthesia for 3 hours.Patient reportedly fully recovered with no residual effects and there was no other patient consequence.The patient was to be rescheduled to do another ablation procedure.Device evaluation details: the device evaluation has been completed.The carto 3 system was tested by technical service after the case.No failure was found.The study data was requested by the device manufacturer to investigate the issue.Sales representative reported that the data wasn't available as it was deleted previously and confirmed that there have not been any issues since.The system is operational.A manufacturing record evaluation was performed for the carto 3 system 14719, 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 ref.# (b)(4).

• Brand Name: CARTO 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 9497692
• MDR Text Key: 199724164
• Report Number: 2029046-2019-04025
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• 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
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 71CM TRANSSEPTAL NEEDLE.; BI DIR 7FR DEFL CS CATH,NON.; CARTO3 EXTERNAL REFPATCH 6PACK.; CBL, 34 HYP/34 LEMO, 10'.; CBL,34 HYP/10 LEMO,BLU,10'.; PENTARAY NAV ECO 7FR, D, 2-6-2.; PREF.GUIDING SHEATH W/MULT.CRV.; SMARTABLATE IRR TUBE SET.; SOUNDSTAR ECO GE 10F CATHETER.; SPLIT HANDLE EXT. CABLE, 9' LG.; THMCL SMTCH SF UNID, TC, F.