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

Catalog Number FG540000

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2018

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.Still pending is the manufactured date.Therefore, a supplemental report will be submitted to update the manufactured date.Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system and a map shift occurred with no error message.It was stated that the map shift was obvious.Fluoroscopy was not used during the procedure.The x-ray tube was moved away from the patient table.No patient consequence was reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since there was a map shift with no error message and there was no evidence that there was patient movement or a cardioversion performed, this event is assessed as a reportable malfunction.

Manufacturer Narrative

Investigation summary: it was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system and a map shift occurred with no error message.It was stated that the map shift was obvious.Fluoroscopy was not used during the procedure.The x-ray tube was moved away from the patient table.No patient consequence was reported.The biosense webster field service engineer spoke with the biosense webster field representative.The biosense webster field representative reported the account had no issues on the next case with the carto system, but the account would still like the system tested.The biosense webster field service engineer arrived on site and discovered exposed wires on the location pad cable and that the mapping port in the patient interface unit had a bent pin.The biosense webster field service engineer installed replacement location pad cable kit and replaced the backplane card in the patient interface unit.System passed acceptance testing procedure tests.The biosense webster field service engineer completed a preventative maintenance on the carto system.The issue was not reproduced; however, they found damaged parts were replaced and can contribute to the reported issue.The system is in service and ready for use.The device history record (dhr) review was performed by the manufacturer and no anomalies, which are related to the reported issue were noted in manufacturing or servicing of this equipment.Manufacturer's ref.No: (b)(4).

Manufacturer Narrative

The manufactured date was provided on november 11, 2018.Therefore, manufactured date has been populated.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: 8057722
• MDR Text Key: 128441619
• Report Number: 2029046-2018-02258
• 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,Followup
• Report Date: 10/10/2018

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: FG540000
• Initial Date Manufacturer Received: 10/10/2018
• Initial Date FDA Received: 11/09/2018
• Supplement Dates Manufacturer Received: 11/11/2018; 11/25/2018
• Supplement Dates FDA Received: 11/18/2018; 12/04/2018
• Patient Sequence Number: 1