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

Model Number FG540000

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/13/2020

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. additionally, if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift issue occurred.It was reported that there was noise displayed on the body surface (bs) and ablation channels on the carto® 3 system and recording system.The auxiliary pacing cable was replaced and the issue was resolved.During the interference no other ecg signal was available for the physician to monitor the patient¿s heart rhythm (such as defibrillator, anesthesia monitor, etc.).The procedure was continued.There was no report of patient consequence.This event will be conservatively reported under the carto® 3 system since the auxiliary pacing cable is an accessory.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift issue occurred.It was reported that there was noise displayed on the body surface (bs) and ablation channels on the carto® 3 system and recording system.The auxiliary pacing cable was replaced and the issue was resolved.During the interference no other ecg signal was available for the physician to monitor the patient¿s heart rhythm (such as defibrillator, anesthesia monitor, etc.).The procedure was continued.There was no report of patient consequence.Device evaluation details: the device evaluation has been completed.The technical support representative confirmed that a replacement of the jb pacing aux.Cable was delivered to the customer and installed.The system is ready for use.The suspected cable was requested for return, however, it was confirmed that the cable was disposed of, therefore, it will not be possible to investigate the cable.The manufacturing record evaluation was performed on carto 3 # 14692, 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 ref # (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: 9931767
• MDR Text Key: 202099172
• Report Number: 2029046-2020-00521
• 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
• Type of Report: Initial,Followup
• Report Date: 03/13/2020

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 Model Number: FG540000
• Device Catalogue Number: FG540000
• Initial Date Manufacturer Received: 03/13/2020
• Initial Date FDA Received: 04/06/2020
• Supplement Dates Manufacturer Received: 04/23/2020
• Supplement Dates FDA Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1