MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO 3 SYSTEM; SIMILAR DEVICE FG540000, 510K # K042999

Catalog Number FG540000J

Device Problem Pacing Problem (1439)

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

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 number: pc-(b)(4).

Event Description

It was reported that an unknown patient underwent atrial fibrillation (afib) with carto 3 system.The patient experienced unwanted pacing.During the procedure, an emergency pacing took place.When vvi pacing was conducted, vpacing is in place when vvi is not in time.The procedure was successfully completed without patient's consequence.The unwanted pacing is mdr-reportable.

Manufacturer Narrative

On 29-dec-2021, the product investigation was completed.It was reported that an unknown patient underwent atrial fibrillation (afib) with carto 3 system.The patient experienced unwanted pacing.During the procedure, an emergency pacing took place.When vvi pacing was conducted, vpacing is in place when vvi is not in time.Device evaluation details: although initially it was reported that the issue occurred when an emergency pacing was performed, it was confirmed during investigation that the pacing was performed from ref/deca port using decanav catheter, and not from emergency port, and that the pacing was not an emergency pacing, but kind of planned pacing.It was confirmed that about 20 seconds after pacing was finished, there was one beat different than the others.No indication for carto performing any pacing during that time.No artifact resembling stimulus is observed on any of the bs ecg leads.There was no unwanted pacing delivered during the procedure and the system behavior was correct.System is operational.A manufacturing record evaluation was performed for the carto 3 system # 50067, 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: SIMILAR DEVICE FG540000, 510K # K042999
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11959866
• MDR Text Key: 266004868
• Report Number: 2029046-2021-00887
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• 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
• Date Manufacturer Received: 12/29/2021
• Was Device Evaluated by Manufacturer?: No
• 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