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

Catalog Number FG540000J

Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408)

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

Event Date 11/08/2022

Event Type  malfunction  

Event Description

It was reported that an unknown patient underwent an unknown ablation procedure with a carto 3 system.It was reported that when performing ablation, the display disappeared, and the map was misaligned.Timing when complaints occurred was timing of starting ablation about 2 hours after entry of the patient to the room.Readjustment of cable wiring, replacement of stsf cable, and replacement of catheter was attempted, but no improvement was obtained.The position of the indifferent electrode (patch) plate was reconsidered and replaced.The issue was resolved.The procedure was then completed without any problem.Version information: v 7.2.40.250.The procedure was successfully completed without patient's consequence."the display disappeared" is related to catheter visualization.The issue was seen during ablating.No error was seen.Regarding map shift, it was confirmed that when the visitag was attached when the ablation was continued, the location was different compared with the ¿pre¿s fam.Univu¿ image.When the ablation was started from the position considered to be correct, there was an impression that the tip of the ablation catheter falls 3 ~ 4 tips downward.Cardioversion has not been performed.The patient did not move.Catheter visualization is not mdr-reportable.Map shift without error message or patient movement/cardioversion is mdr-reportable.

Manufacturer Narrative

Initial reporter phone: (b)(6).Investigation summary: it was reported that during ablation the catheter disappeared and the map shifted.Fse confirmed that the issue was resolved by changing the position of the indifferent electrode.System is ready for use.The history of customer complaints reported during the last year associated with carto 3 system (b)(4) was reviewed.No similar complaints were found there out of 4 additional complaints.A manufacturing record evaluation was performed for the system (b)(4), and no non-conformances related to the reported complaint condition were identified.The complaint investigation results will be used for monitoring and detecting statistical signals per complaint trending and signal detection process.No capa is initiated as the available information and results of the investigation do not meet the capa triggers.Device history lot: null.Device history batch: null.Device history review: null.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

On 15-feb-2023, the product investigation was completed.It was reported that an unknown patient underwent an unknown ablation procedure with a carto 3 system.It was reported that when performing ablation, the display disappeared, and the map was misaligned.Timing when complaints occurred was timing of starting ablation about 2 hours after entry of the patient to the room.Readjustment of cable wiring, replacement of stsf cable, and replacement of catheter was attempted, but no improvement was obtained.The position of the indifferent electrode (patch) plate was reconsidered and replaced.The issue was resolved.The procedure was then completed without any problem.Version information: v 7.2.40.250.The procedure was successfully completed without patient's consequence.Device evaluation details: field service engineer (fse) confirmed that the issue was resolved by changing the position of the indifferent electrode.System is ready for use.A manufacturing record evaluation was performed for the system 50570, 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).

Manufacturer Narrative

On 1-apr-2023, bwi received information indicating that the device's manufacture date was 22-nov-2012.The h4 manufacture date section of this report has been updated accordingly.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 (FOR JAPAN)
• 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: 16380246
• MDR Text Key: 309592999
• Report Number: 2029046-2023-00306
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 04/24/2023

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: FG540000J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 02/15/2023
• Supplement Dates Manufacturer Received: 02/15/2023; 04/01/2023
• Supplement Dates FDA Received: 03/10/2023; 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/22/2012
• 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: THERMOCOOL SMARTTOUCH.