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

Catalog Number FG540000

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2018

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.Still pending is the manufactured date.Therefore, a supplemental report will be submitted to update the manufactured date.Concomitant product: lasso navigational variable eco catheter, us catalog #: d134301, lot #: 30025169l.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure under general anesthesia with a carto® 3 system and a ¿map shift ¿ no error message ¿ no patient movement/cardioversion¿ occurred.In addition, a lasso navigational variable eco catheter was used and a ¿magnetic sensor error¿ occurred.During mapping, 60 minutes into the procedure, error 116 (magnetic sensor error) displayed.Physician was unable to create a fast anatomical map (fam) with the lasso navigational variable eco catheter.Catheter cable was disconnected from the lasso navigational variable eco catheter.Catheter cable was disconnected and reconnected on the catheter end.Error 116 resolved and the procedure continued.Ninety minutes later, error 116 displayed on the carto® 3 system.Lasso navigational variable eco catheter position was moved from the left pulmonary vein to the right pulmonary vein.At this point, the lasso navigational variable eco catheter did not appear in the same location as it did when previously mapped in the right superior pulmonary vein.Troubleshooting the connections was performed (as above) and the location difference of the lasso navigational variable eco catheter persisted, as the original map did not match with the new location of the lasso navigational variable eco catheter on the map.Ablation catheter (unspecified) was also moved to this location (unspecified) and it could also be positioned into this new space (unspecified).This made the system appear as if there was patient movement.There were no patient movement alarms on the carto® 3 system.There were no metal interference errors.It was noted that although the patient was under general anesthesia and intubated, they did cough one time at the beginning of the procedure.Physician indicated that the lasso catheter cable connection was loose.When the physician manipulated the connection, the issue was transiently resolved, but resumed upon releasing the connection.Lasso navigational variable eco catheter was replaced and the error resolved.A new map of the right pulmonary veins was created and the procedure was completed without patient consequences.New map of the right pulmonary veins had a different location than the first map.Upon moving the lasso navigational variable eco catheter back to the left pulmonary veins, it appeared to be in approximately the same location (unspecified).There were no cardioversions performed during the procedure.Fluoroscopy was available.There were no patient consequences reported.The magnetic senor error was assessed as not reportable.The potential risk that it could cause or contribute to a death or serious deterioration in the patient¿s state of health was remote.The mapshift issue was assessed as a reportable issue.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an ablation procedure under general anesthesia with a carto® 3 system.Error 116 displayed on the carto® 3 system.Lasso navigational variable eco catheter position was moved from the left pulmonary vein to the right pulmonary vein.At this point, the lasso navigational variable eco catheter did not appear in the same location as it did when previously mapped in the right superior pulmonary vein.Troubleshooting the connections was performed (as above) and the location difference of the lasso navigational variable eco catheter persisted, as the original map did not match with the new location of the lasso navigational variable eco catheter on the map.Ablation catheter (unspecified) was also moved to this location (unspecified) and it could also be positioned into this new space (unspecified).This made the system appear as if there was patient movement.There were no patient movement alarms on the carto® 3 system.There were no metal interference errors.It was noted that although the patient was under general anesthesia and intubated, they did cough one time at the beginning of the procedure.Physician indicated that the lasso catheter cable connection was loose.When the physician manipulated the connection, the issue was transiently resolved, but resumed upon releasing the connection.Lasso navigational variable eco catheter was replaced and the error resolved.A new map of the right pulmonary veins was created and the procedure was completed without patient consequences.New map of the right pulmonary veins had a different location than the first map.Upon moving the lasso navigational variable eco catheter back to the left pulmonary veins, it appeared to be in approximately the same location (unspecified).There were no cardioversions performed during the procedure.Fluoroscopy was available.A new map of the right pulmonary veins was created, and the procedure was completed without patient consequences.The biosense webster field service engineer (fse) visited the customer to troubleshoot the reported issue.No issue was found.During the hospital visit, the local (fse) performed system preventative maintenance.The preventative maintenance was completed with no observations.The system is fully functional and ready for clinical use.The device history record (dhr) review was performed by the manufacturer and no anomalies, which are related to the reported issue were noted in manufacturing or servicing of this equipment.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The manufactured date has been provided on november 1, 2018.Therefore, manufactured date has been populated.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: 8018012
• MDR Text Key: 125655730
• Report Number: 2029046-2018-02225
• 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
• Report Date: 10/01/2018

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 Catalogue Number: FG540000
• Initial Date Manufacturer Received: 10/01/2018
• Initial Date FDA Received: 10/30/2018
• Supplement Dates Manufacturer Received: 11/01/2018; 11/21/2018
• Supplement Dates FDA Received: 11/18/2018; 12/05/2018
• Patient Sequence Number: 1