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

Model Number FG540000

Device Problems Display or Visual Feedback Problem (1184); Appropriate Term/Code Not Available (3191)

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

Event Date 11/01/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device problem code ¿appropriate term/code not available" represents ¿patient event non serious." 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 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 an idiopathic ventricular tachycardia (idvt) ablation procedure with a carto® 3 system and a map shift with no error message, no patient movement and no cardioversion issue occurred.While mapping, the pvc was originating near the his.The his signal was then showing slightly above than it was originally.The ablation catheter was then used to create new map points and the distance between the new point and the old point was about 7 mm and they did not receive a "learn new" error.They decided to abort the procedure and they consulted with the patient about receiving a pacemaker and continuing with the ablation at a later date.The patient was under local anesthesia for around 5 hours.There was no transseptal puncture performed as the physician had already given heparin and did not feel it was safe to go transseptal after.He plans to go transseptal at a later date to achieve better contact with the area.This was the reason for the case abort.In the physician¿s opinion the cancelation of the procedure did not contribute to a death or a serious injury to the patient.The physician wanted to try more antiarrhythmics first.He also wanted to consult the risk of a pacemaker with the patient because the pvc was originating so close to the his bundle.The patient did not require extended hospitalization due to a medical condition caused by procedure cancellation.There was no medical condition caused by the procedure cancellation.The physician did not perform a cardioversion prior to the map shift.It did not appear that the patient had moved before the map shift.They checked control p to see if the patches had moved.The map shift with no error message, no patient movement and no cardioversion was assessed as a mdr reportable malfunction.The absence of treatment was assessed as patient event non serious and therefore, not mdr reportable.It was not life threatening; did not result in permanent impairment of a body function or permanent damage to a body structure; or did not necessitate medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.

Manufacturer Narrative

The investigation was completed on 09-jun-2022.It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a carto® 3 system.While mapping, the pvc was originating near the his.The his signal was then showing slightly above than it was originally.The ablation catheter was then used to create new map points and the distance between the new point and the old point was about 7 mm and they did not receive a "learn new" error.They decided to abort the procedure and they consulted with the patient about receiving a pacemaker and continuing with the ablation at a later date.The physician did not perform a cardioversion prior to the map shift.It did not appear that the patient had moved before the map shift.They checked control p to see if the patches had moved.The bwi field service representative spoke with the bwi representative, and it was confirmed that the fluoroscopy changed position prior to the shift.It was also confirmed that the physician terminated case due to lack of consent for a pacemaker.It was also confirmed that the system had completed several cases with no further shift.The issue was also investigated at the device manufacturer.It was confirmed the chest patch moved significantly across the study.Metal levels on the chest patch also increased and changed.Although the customer reported that no error messages were displayed by the system, it was confirmed that a metal warning was seen for ultrasound and mapping catheters.At the same time, the back patch did not show significant movement.That is a reason why no proper compensation was made.Anatomical entities as ablation, anatomical points and fast anatomical mapping were taken under different metal conditions hence their location was affected and not coherent.The result is inconsistency of the map- map shift.The complaint history of the system was reviewed.A manufacturing record evaluation was performed for the carto 3 system #34663, 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12849690
• MDR Text Key: 287352102
• Report Number: 2029046-2021-02017
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 11/20/2021
• Supplement Dates Manufacturer Received: 06/09/2022
• Supplement Dates FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND ABLATION CATHETER.