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

Model Number FG540000

Device Problems Appropriate Term/Code Not Available (3191); No Pacing (3268)

Patient Problem Syncope/Fainting (4411)

Event Date 05/17/2022

Event Type  malfunction  

Event Description

It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system.They were not able to emergency pace and the patient experienced a vagal response during the bradycardia.It was reported that during the afib ablation procedure, they were not able to pace with the carto® 3 system.The cable was changed, as well as the pin box and catheter; however, the issue still persisted.The patient interface unit (piu) and carto® software were turned off and restarted.This caused a 30-minute delay in the procedure.The patient experienced a vagal response during bradycardia and physician was not able to pace to restore normal sinus rhythm.The patient did not require extended hospitalization.In the physician¿s opinion, the delay did not contribute to a serious injury to the patient.Pacing leads were connected to carto® piu primary pacing port.The carto® did not allow pacing from any other catheters connected through the piu.The pacing stimulator was a biotronik device.The pacing was emergency pacing and there was not any unwanted pacing being delivered.The vagal response was assessed as not mdr reportable.The pacing issue was assessed as a mdr reportable product malfunction.

Manufacturer Narrative

Initial reporter address line 2 (cont.): (b)(6).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: (b)(4).

Manufacturer Narrative

The hardware investigation was completed on 11-aug-2022.It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system.They were not able to emergency pace and the patient experienced a vagal response during the bradycardia.Hardware investigation details: the bwi field service engineer (fse) checked the system and could not reproduced the issue.The issue was investigated by the device manufacturer and was not able to reproduce the issue.No root cause can be identified.The system was ready for use.The history of customer complaints reported during the last year associated with carto 3 system # (b)(6) was reviewed.No similar complaints were found.A manufacturing record evaluation was performed for carto 3 system # (b)(6), 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: 14692589
• MDR Text Key: 296181171
• Report Number: 2029046-2022-01310
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• 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?: Yes
• Date Manufacturer Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2010
• 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: UNK BIOTRONIK PACING STIMULATOR; UNK BRAND CABLE; UNK BRAND CABLE; UNK BRAND CATHETER; UNK BRAND CATHETER
• Patient Sex: Male