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

Model Number FG540000

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/12/2020

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent an atrial flutter right (r-afl) procedure with a carto® 3 system and a map shift occurred with no error message, no cardioversion and no patient movement.Initially it was reported that during the procedure, after the physician changed out the sheath, there was a map shift with no errors or alerts displayed on the carto® 3 system.The map shift was off by about 1 cm at most and about 1/3 cm off at the least.They had the same rhythm in between.The location pad was not moved at all.The catheter was re-zeroed without resolution.The physician declined replacing the catheter.The catheter was disconnected and reconnected without resolution.The physician was in steep rao and they went back to ap to try and regularize the metal value and the issue remained.The procedure was continued by remapping with the ablation catheter.No patient consequence was reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.With the information available, the map shift described was assessed as not reportable.Additional information was received on the event on march 31, 2020.There was no error given by the system but mid case, upon exchanging sheaths and re-inserting the ablator, the catheter was noticeably further from the previously collected fast anatomical mapping (fam) and visitags.This issue was present during both mapping and ablating, the catheter position did not change depending on if they were mapping or ablating.The approximate difference in catheter location varied and ranged between about 1/3-1cm of vertical difference.There was no cardioversion prior to the map shift.It was the same rhythm throughout.In addition, on april 7, 2020, it was clarified that there was no noticeable patient movement and the patches had not moved relative to its position at the beginning of the case at the time of the map shift.The map shift with no error messages, no cardioversion and no patient movement was assessed as a reportable malfunction.The awareness date was reset to the additional information received on march 31, 2020.

Manufacturer Narrative

Device investigation summary: it was reported that a patient underwent an atrial flutter right (r-afl) procedure with a carto® 3 system.During the procedure, after the physician changed out the sheath, there was a map shift with no errors or alerts displayed on the carto® 3 system.The map shift was off by about 1 cm at most and about 1/3 cm off at the least.They had the same rhythm in between.The location pad was not moved at all.The catheter was re-zeroed without resolution.The physician declined replacing the catheter.The catheter was disconnected and reconnected without resolution.The physician was in steep rao and they went back to ap to try and regularize the metal value and the issue remained.The procedure was continued by remapping with the ablation catheter.No patient consequence was reported.Additional information was received on the event.There was no error given by the system but mid case, upon exchanging sheaths and re-inserting the ablator, the catheter was noticeably further from the previously collected fast anatomical mapping (fam) and visitags.This issue was present during both mapping and ablating, the catheter position did not change depending on if they were mapping or ablating.The approximate difference in catheter location varied and ranged between about 1/3-1cm of vertical difference.There was no cardioversion prior to the map shift.It was the same rhythm throughout.It was clarified that there was no noticeable patient movement and the patches had not moved relative to its position at the beginning of the case at the time of the map shift.A follow-up was performed with the with the biosense webster, inc.Field representative and was advised that several follow-up cases have been completed successfully.The reported issue was not duplicated.No further service was requested.System is ready for use.Data related to the reported issue was sent to the device manufacturer.The issue was investigated at the device manufacturer.It was found that the user worked with high metal levels at the chest patch and from time to time at the catheter.The chest patches experienced much higher values of metal than the back patches.The effect was that the bcs correction from the back patches was not accurate for the chest patches and the catheter.Also, cpm was built during the time when the mapping catheter was under high metal conditions.The magnetic location used by the system to construct the cpm was strongly affected by this metal.With such distorted cpm, the acl appears shifted with respect to previously acquired data regardless of the fluoroscopy position as the cpm is already built.The issue is related to a software defect.The defect is being handled per software defect management procedure.System is operational.A manufacturing record evaluation was performed for the carto 3 system 11431, and no internal actions related to the reported complaint condition were identified.An internal corrective action has been opened to investigate map shifts.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: 9949065
• MDR Text Key: 201942798
• Report Number: 2029046-2020-00537
• 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
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• 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: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THMCL SMTCH SF BID, TC, D-F; UNKNOWN BRAND PATCHES; UNKNOWN BRAND SHEATH; UNKNOWN BRAND SHEATH