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 09/12/2019

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.Manufacturer's reference # (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system and a map shift error occurred.It was initially reported that the catheter had required to be zeroed out many times throughout the case due to an invalid force measure.It was also noted that the map shifted 3 mm after ablating.On september 20, 2019, additional information was received indicating that the map shift was discovered by doing a post voltage map using confidence and a pentaray catheter.The voltage map showed healthy voltage approximately 3 mm to the left of the left pulmonary vein, wide antral circumferential ablation (waca) lesion on the posterior wall (when looking in a post anterior view) and showed scar (<0.2 mv) to the left of the right pulmonary vein wide antral circumferential ablation (waca).No change occurred in patch location and all metal values were well below limits as the fluoroscopy system was never near the patient for the entirety of the case.No cardioversion was performed, and no posture change of the patient occurred.The catheter was not replaced, and no patient consequence was reported.The observed force issue was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The observed map shift was assessed as an mdr reportable malfunction as map shifted with no error message, patient movement, or cardioversion.

Manufacturer Narrative

On 5/5/2020, biosense webster inc.Received additional details about how the map shift issue was resolved during the case.It was reported that working with both the physician and the staff to ensure that magnetic interference was minimized from all possible factors.Since that event, they have not had the problem.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system and a map shift issue occurred.It was noted that the map shifted 3 mm after ablating.No error message was generated.Additional information was received indicating that the map shift was discovered by doing a post voltage map using confidence and a pentaray catheter.The voltage map showed healthy voltage approximately 3 mm to the left of the left pulmonary vein, wide antral circumferential ablation (waca) lesion on the posterior wall (when looking in a post anterior view) and showed scar (0.2 mv) to the left of the right pulmonary vein wide antral circumferential ablation (waca).No change occurred in patch location and all metal values were well below limits as the fluoroscopy system was never near the patient for the entirety of the case.No cardioversion was performed, and no posture change of the patient occurred.The catheter was not replaced, and no patient consequence was reported.Device evaluation summary was completed on june 23, 2020.The procedure finished with no issues to patient.It was reported that they worked with both the physician and the staff to minimize magnetic interference during the procedure from all possible factors.The biosense webster, inc.Representative confirmed the issue was not duplicated since the complaint was reported.The biosense webster, inc.Representative reported that the data is not available because it was overwritten by the system due to time period.In addition, the history of customer complaints associated with this specific system were reviewed and it was found that the issue was not reported anymore.It was reported by the biosense webster, inc.Representative that service on the system was not requested because no more complaints regarding the map shift occurred.System is operational.A manufacturing record evaluation was performed for the system (b)(4), and no internal actions related to the reported complaint condition were identified.An internal corrective action has been opened to investigate ¿map shifts can occur without any warning or error message displayed on screen¿.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

Correction: on 4/22/2020, during an internal review of the record it was noticed that the thmcl smtch sf bid, tc, f-j was inadvertently omitted from the d11.Concomitant med.Product field in the initial 3500a medwatch report.It was also noticed that the carto 3 system was listed incorrectly listed in the d11.Concomitant med.Product field in the initial 3500a medwatch report.The carto 3 system is not a concomitant product but the actual suspect medical device.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref # (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: 9160274
• MDR Text Key: 193121767
• Report Number: 2029046-2019-03731
• 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,Followup
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2019
• 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: 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; GENERIC - PENTARAY; THMCL SMTCH SF BID, TC, F-J