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

Model Number FG540000

Device Problems Signal Artifact/Noise (1036); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

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.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 during an unspecified cardiac ablation procedure, there was noise on the body surface (bs) electrocardiogram (ecg), as well on the map catheter and on the lasso catheter signals.The noise was observed on the carto® 3 system and ep recording system.The physician did not have any signal available to monitor the patient¿s heart rhythm.The remainder of the procedure was aborted.The patient had been under general anesthesia for 3 hours.A transseptal puncture had been performed prior to the case cancellation.No patient consequences were reported.The procedure had been stopped.The physician did not consider the procedure cancellation to represent a risk to the patient's health status.This cancellation is not an mdr-reportable issue.The noise issue is not an mdr-reportable issue.However, the lack of signal to monitor cardiac rhythm is an mdr-reportable issue.

Manufacturer Narrative

On (b)(6)2020, the product investigation was completed.It was reported that during an unspecified cardiac ablation procedure, there was noise on the body surface (bs) electrocardiogram (ecg), as well on the map catheter and on the lasso catheter signals.The noise was observed on the carto® 3 system and ep recording system.The physician did not have any signal available to monitor the patient¿s heart rhythm.The remainder of the procedure was aborted.The patient had been under general anesthesia for 3 hours.A transseptal puncture had been performed prior to the case cancellation.No patient consequences were reported.The procedure had been stopped.Device evaluation details: the field service engineer received information indicating that the customer has done two following cases and did not face any noise issue using the same setup as before.Isolated noise issue.Any service to the system was declined.The system is in service and ready for use.The complaint history of the system was reviewed, and no more similar problems were found since the issue occurred.A manufacturing record evaluation was performed for the carto 3 system # 11886, 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; 33 technology drive; irvine CA 92618
• MDR Report Key: 10738783
• MDR Text Key: 230274754
• Report Number: 2029046-2020-01520
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• 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
• Date Manufacturer Received: 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EP RECORDING SYSTEM; LASSO CATHETER; UNK_TRANSEPTAL NEEDLE; UNSPECIFIED MAPPING CATHETER