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

Catalog Number FG540000

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 03/22/2024

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: the manufacturer investigated the issue.After reviewing the received data, it was found that the carto 3 system displayed a pop-up message that indicated that the visualization shall be affected.It was also seen that the user approved this pop-up message by clicking the "i approve button" on the screen.In addition, according to carto 3 instructions for use: "switching generators during a study is not recommended, because catheter visualization will be affected.If you switch generators, you must disconnect the rf generator, exit the study, connect the second generator, and continue from review mode.Follow standard procedure for preparing the generator and fluoroscopy device before initializing catheter visualization.".Issue is related to user error.The manufacturing record evaluation was performed on carto 3 system #(b)(4), 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).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a carto 3 system and a map shift was noted.After swapping generators, the map shift persisted--but in a different direction.The approximate different in catheter location from the one displayed was 15 mm.No cardioversion was performed nor was there patient movement prior to the shift.There were no error messages on the equipment.There were no faults/issues seen with the generators or the catheters.The medical team then proceeded by recollecting new fast anatomical mapping (fam) and points.The procedure continued.No patient consequences were reported.

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19122026
• MDR Text Key: 341015020
• Report Number: 2029046-2024-01264
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/21/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: NGEN GENERATOR.; NGEN PUMP.; TRUPULSE SYSTEM.; VARIPULSE CATHETER.