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

Model Number FG540000

Device Problems Computer Software Problem (1112); Communication or Transmission Problem (2896); Appropriate Term/Code Not Available (3191)

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

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device problem code of ¿appropriate term/code not available" represents "delay procedure-high risk".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.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 a patient underwent cardiac ablation procedure with a carto® 3 system where a procedure cancellation with high patient risk occurred.It was reported that the smartablate generator stopped ablating.There was an error saying impedance too high.They exchanged the ablation cable and the issue persisted.The catheter and the indifferent electrodes were exchanged and the issue persisted.They rebooted the generator and the issue persisted.The caller also exchanged the cable from the generator to the patient interface unit (piu) and the issue persisted.A css (rh) was called to further assist.The caller was advised to toggle back and forth the pacer indicator and the issue persisted.The pacing was closed on the carto® 3 system.The caller was advised if they saw any bent pins in the catheter and the piu; however, no damage was noted.The caller was then advised to reboot the piu and to disconnect and reconnect all cables and catheters into the piu.The caller confirmed the correct catheter was selected on the carto® 3 system.There was no error code being displayed.Only impedance was at maximum.After the reboot, the caller was then advised to exchange the ablation catheter and the issue persisted.The ablation catheter had the same lot number as the previous and they were advised to use a new catheter with a different lot number.The caller stated that all the catheters had the same lot number.They then opened a bi-directional catheter smart touch sf.They did not get an impedance reading.The caller was advised that the generator would then need to be exchanged.However, they did not have one available to exchange it with.The caller was advised to make sure the mapping catheter says none and they still have no impedance.The caller will call back when they are able to exchange the smartablate generator.The caller called back and they are using a demo smartablate generator and they are still not getting any impedance.A css(rh) was called to further troubleshoot.The caller confirmed a new catheter and cable are being used and the issue persists.The generator was still not showing any impedance.The caller was advised to replace the grounding pads with new pads and different lot numbers.When they unplugged the grounding pad, they get some artifact which is typically seen when they are not plugged in.The on-call biosense webster, inc.Field representative (kh) was called to further troubleshoot.The caller was advised the local biosense webster, inc.Field representative will need to be dispatched for the unresolved issue.The biosense webster, inc.Field representative confirmed all the steps that were taken and all cables that were exchanged were new.The piu was serviced last thursday 10/15/20.The caller states the issue started about mid-case and on the eleventh ablation and the ablation stopped.The caller was advised to replace the grounding pads again, but the caller states the physician was done with the case.The communication issue was assessed as not mdr reportable.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.On (b)(6) 2020 the clinical specialist notified that the procedure was aborted.On (b)(6) 2020 the bwi representative confirmed that the patient was under general anesthesia and transseptal was already performed before the procedure was aborted.No injury occurred.The physician only opined to the risk of the patient.The patient was discharged and will return to complete the ablation.After review of the additional information received on 10/30/2020, the procedure cancellation was assessed as mdr reportable for procedure cancellation with high patient risk.The awareness date for this reportable assessment is (b)(6) 2020.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference #: (b)(4) per an internal review, noted on (b)(6) 2020 a correction to the 3500a initial as in h10.Additional manufacturer narrative it was reported, ¿h6.Medical device problem code of ¿appropriate term/code not available" represents "delay procedure-high risk".¿ however, it should have stated, ¿h6.Medical device problem code of ¿appropriate term/code not available" represents "cancellation procedure-high risk".

Manufacturer Narrative

The investigation summary was completed on 12/30/2020.It was reported that a patient underwent cardiac ablation procedure with a carto® 3 system where a procedure cancellation with high patient risk occurred.It was reported that the smartablate generator stopped ablating.There was an error saying impedance too high.They exchanged the ablation cable and the issue persisted.The catheter and the indifferent electrodes were exchanged and the issue persisted.They rebooted the generator and the issue persisted.The caller also exchanged the cable from the generator to the patient interface unit (piu) and the issue persisted.A css (rh) was called to further assist.The caller was advised to toggle back and forth the pacer indicator and the issue persisted.The pacing was closed on the carto® 3 system.The caller was advised if they saw any bent pins in the catheter and the piu; however, no damage was noted.The caller was then advised to reboot the piu and to disconnect and reconnect all cables and catheters into the piu.The caller confirmed the correct catheter was selected on the carto® 3 system.There was no error code being displayed.Only impedance was at maximum.After the reboot, the caller was then advised to exchange the ablation catheter and the issue persisted.The ablation catheter had the same lot number as the previous and they were advised to use a new catheter with a different lot number.The caller stated that all the catheters had the same lot number.They then opened a bi-directional catheter smart touch sf.They did not get an impedance reading.The caller was advised that the generator would then need to be exchanged.However, they did not have one available to exchange it with.The caller was advised to make sure the mapping catheter says none and they still have no impedance.The caller will call back when they are able to exchange the smartablate generator.The caller called back and they are using a demo smartablate generator and they are still not getting any impedance.A css(rh) was called to further troubleshoot.The caller confirmed a new catheter and cable are being used and the issue persists.The generator was still not showing any impedance.The caller was advised to replace the grounding pads with new pads and different lot numbers.When they unplugged the grounding pad, they get some artifact which is typically seen when they are not plugged in.The on-call biosense webster, inc.Field representative was called to further troubleshoot.The caller was advised the local biosense webster, inc.Field representative will need to be dispatched for the unresolved issue.The biosense webster, inc.Field representative confirmed all the steps that were taken and all cables that were exchanged were new.The piu was serviced 10/15/20.The caller states the issue started about mid-case and on the eleventh ablation and the ablation stopped.The caller was advised to replace the grounding pads again, but the caller states the physician was done with the case.On 10/29/2020 the clinical specialist notified that the procedure was aborted.On 10/30/2020 the bwi representative confirmed that the patient was under general anesthesia and transseptal was already performed before the procedure was aborted.No injury occurred.The physician only opined to the risk of the patient.The patient was discharged and will return to complete the ablation.The biosense webster, inc.Field representative visited the account and replaced the backplane card with a new one.The biosense webster, inc.Field representative performed an acceptance testing procedure.The issue was resolved.The system is ready for use.The defective backplane card was sent to the device manufacturer for investigation.The customer complaint was confirmed.Internal disconnection of the ablation line in the backplane card caused the reported problem.The card could not be repaired and was moved to scrap.A manufacturing record evaluation was performed for the system # 14658 and the backplane card, and no internal actions related to the reported complaint condition were identified.During an internal review on 12/30/2020 a reassessment was noted to h6.Medical device problem code as it was initially reported as ¿communication or transmission problem (a13)¿.It was reassessed to ¿computer software problem (a11)¿.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 10901061
• MDR Text Key: 219527379
• Report Number: 2029046-2020-01806
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• 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: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8MM NON NAVIGATION BI-DIRECT.; CARTO3 EXTERNAL REFPATCH 6PACK.; CBL, 34 HYP/34 LEMO, 10'.; CBL, 34 HYP/34 LEMO, 10'.; CBL, 34 HYP/34 LEMO, 10'.; CBL,25 HYP/34 HYP,RED,10'.; PENTARAY NAV ECO 7FR, D, 2-6-2.; SMARTABLATE CATH CBL (TC/THR).; SMARTABLATE IRR TUBE SET.; SOUNDSTAR ECO GE 10F CATHETER.; SPLIT HANDLE EXT. CABLE, 9' LG.; THMCL SMTCH SF BID, TC, D-F.; THMCL SMTCH SF UNID, TC, F.