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

Model Number FG540000

Device Problems Poor Quality Image (1408); Computer Operating System Problem (2898)

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

Event Date 04/14/2022

Event Type  malfunction  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.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 an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system.There was a map shift with no patient movement or cardioversion.It was reported that the carto 3 system crashed while in the middle of mapping.The system showed a black screen and then the application reloaded on its own without any error messages displayed.When they reloaded the map, the anatomical geometry was shifted in the superior access approx.15-20 cm.They confirmed on ultrasound that there had been a map shift.They created a new map to continue the procedure and stated that the new map was very unstable for the rest of the procedure.The vizigo sheath also stopped being visualized sometime later in the case.Custom template was in use.Software version confirmed 7.1.80.33.Part of a clinical trial - tailored ¿ af by volta medical.No patient consequences were reported.No error was provided by the system.They could confirm large shift on ultrasound as superior vena cava (svc) was located in the inferior vena cava (ivc) of previous map.The issue was seen during mapping.The approximate difference in catheter location before and after map shift was 20 cm (cm is not typo).The physician did not perform cardioversion prior to the map shift and there was no patient movement.Bwi company representative can confirm that the study is not sponsored by bwi or jnj.Software crash is not mdr-reportable.Catheter visualization issue is not mdr-reportable.Map shift with no error message is mdr-reportable.

Manufacturer Narrative

On (b)(6) 2022, the product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system.There was a map shift with no patient movement or cardioversion.Device evaluation details: it was found that the reported map shift was caused due to patient movement.According to carto 3 instructions for use, (p.N.Ug-5400-0072h, rev.P02): "when the relative position between the patches remains the same but the position of the heart relative to the back patches has changed (for example, after repositioning the patient's head on a pillow or moving the patient's arm without changing the patient's position on the mattress, or after the patient is cardioverted), the system will not give a warning and an incorrect map (map shift) might be generated." a manufacturing record evaluation was performed for the carto 3 system # 29173, 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14280389
• MDR Text Key: 290788333
• Report Number: 2029046-2022-00943
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 08/17/2022
• Supplement Dates FDA Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED CATHETER; VIZIGO SHEATH