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 09/17/2020

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 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 a paroxysmal atrial fibrillation (afib) procedure with a carto® 3 system where a map shift with no error message, no patient movement and no cardioversion issue occurred.It was initially reported that during the procedure, they had a map shift of the left atrium 2 times.They made another map after the first map shift; when had a second map shift, made a third map.No error on the screen and no alarm.It was also reported that they were using qdot, and the proximal electrode of the catheter appeared like a ring.Completed the procedure with no consequence.There was about a 30 minute delay.Attempts have been made to obtain clarification to this complaint.However, with the information available, the map shift, catheter visualization and procedure delay issues were assessed as not mdr reportable.Additional information was received on 9/22/2020.There was no error message observed.The map shift was discovered because the catheters were outside the fast anatomical mapping (fam) during mapping and during ablation.The difference was approximately 1 or 2 cm.No patient movement or cardioversion prior to the map shift.In physician¿s opinion the delay did not contribute to a death or a serious injury of the patient.The map shift with no error message, no patient movement and no cardioversion was assessed as a mdr reportable malfunction.The awareness date for this reportable issue is 9/22/2020.As there was no risk to the patient as a result of the procedure delay, both the procedure delay and the catheter visualization issues remain assessed as not mdr reportable.

Manufacturer Narrative

Additional information was received on 11/16/2020 and 11/17/2020.It was clarified that the issue with the qdot catheter was not related to the catheter visualization, but it was a char on the proximal electrode of the catheter which had the shape of a ring.The physician saw char on proximal tip at the end of the procedure.There were no issues with temperature nor irrigation.The ablation parameters were qmode + control mode.60° temperature target, 65° cutoff, temperature from 35° to max 60°, impedance from 90 to 140 ohm and power 90 watts.The patient was anticoagulated with act 300-350 reached during the procedure.There weren¿t lesions in which the contact force was greater than 40 grams but in any case the applications were only for less than 4 s.The irrigation setting was 2ml/min for mapping, 8ml/min for ablation.The pre-ablation high irrigation setting was 8ml/min.Normal saline used as irrigation fluid.No carto visitag used because of qmode + applications.The patient did not exhibit any neurological symptoms since the procedure was completed.The physician does consider the char amount excessive but as posing potential risk to the patient.There were no error messages.Completed the procedure with no consequence.The char issue was assessed as not mdr reportable.Char is a physical phenomenon of radio frequency energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.In addition, additional concomitant products have been provided.Therefore, added these concomitant products to the "d10.Concomitant medical products and therapy dates" field.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The device evaluation was completed on (b)(6) 2020.It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a carto® 3 system.It was initially reported that during the procedure, they had a map shift of the left atrium 2 times.They made another map after the first map shift; when had a second map shift, made a third map.No error on the screen and no alarm.Additional information was received on 9/22/2020.There was no error message observed.The map shift was discovered because the catheters were outside the fast anatomical mapping (fam) during mapping and during ablation.The difference was approximately 1 or 2 cm.No patient movement or cardioversion prior to the map shift.Completed the procedure with no consequence.There was about a 30 minute delay.The biosense webster, inc.Field service engineer contacted the customer and was advised that they had 2 issues: map shift and the dvi to hdmi adaptor was broken.Biosense webster, inc.Field service engineer sent guidelines for map shift and a new adaptor has been ordered.Technical services (ts) confirmed that the damaged dvi to hdmi adaptor was replaced and this issue was resolved.Data related to the reported map shift issue was sent to the device manufacturer.The issue was investigated at the device manufacturer.It was found that the user mapped with qdot at high alternating metal levels.These metal levels were near the warning level and sometimes beyond it, yet acquire action is enabled.It looks as the user changed the fluoroscopy position after mapping was started and there was a strong effect on the chest patch position and metal level.This was hardly seen at the back patch, so if there was any compensation it was very small and did not reflect what changed at the chest patch.The catheter is sensing similar metal ambient as the patch does.The change in metal ambient and the acquire action under significantly different metal levels created nonconsistency in the map known as map shift.System is operational.It was also reported that they were using qdot, and the proximal electrode of the catheter appeared like a ring.The issue was investigated at the device manufacturer.Clarifications were received about the reported issue.It was confirmed that the issue with the qdot catheter was not related to the catheter visualization, but it was a char on the proximal electrode.Some blood near the proximal electrode had been burnt due to the high power of qmode+.A manufacturing record evaluation was performed for the carto 3 system # 001394, and no internal actions related to the reported complaint condition were identified.An internal corrective action has been opened to investigate the map shift issue.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: 10702789
• MDR Text Key: 228600709
• Report Number: 2029046-2020-01507
• 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: foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2020

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
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/20/2020
• Supplement Dates Manufacturer Received: 11/16/2020; 12/14/2020
• Supplement Dates FDA Received: 12/08/2020; 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NGEN PUMP, EU CONFIGURATION; NGEN RF GENERATOR; QDOT MICRO, UNI, TC, F