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 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 information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Note.Date of event is unknown, as such, the field has been left blank.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 cardiac ablation procedure with a carto¿ 3 system where an unexplained map shift occurred.It was reported that the carto¿ 3 system showed over 6 mm shifted up in the maps.There was no patient consequence.On 10/28/2020, biosense webster inc.Received additional information which indicated there was no error displayed on carto but the map was within acl tolerance.The issue was seen during remap after some ablation.It was approximately 6 mm difference or more of a shift.Noticeably different - the superior vein was where the inferior vein was previously.We noticed high forces within the map when the physician looked like he was far from the roof and floating.There was no cardioversion or patient movement.The originally reported map shift issue was considered non-reportable until bwi became aware of additional information on 10/28/2020 which confirmed there was no patient movement or cardioversion and reassessed the event as mdr reportable.

Manufacturer Narrative

It was reported that a patient underwent cardiac ablation procedure with a carto® 3 system where an unexplained map shift occurred.It was reported that the carto® 3 system showed over 6 mm shifted up in the maps.There was no patient consequence.Device evaluation details: the device evaluation has been completed.It was reported that the biosense webster inc.(bwi) field service engineer (fse) performed a preventative maintenance test in the lab and it passed inspection after the complaint was called in.The study data was requested by the device manufacturer to investigate the issue, however, the biosense webster inc.Representative reported that the workstation was replaced due to frequently recurring software crashes caused at previous cases, and the recordings related to the case are not available more.Based on the provided information the investigation of the map shift issue was not possible.Bwi representative confirmed that the issue has not occurred since then.The system is operational.A manufacturing record evaluation was performed for the carto 3 system with serial #(b)(4), and no internal action related to the reported complaint condition were identified.An internal corrective action has been opened to investigate map shifts.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

Hold smp 1.22.

• 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: 10870955
• MDR Text Key: 228350874
• Report Number: 2029046-2020-01787
• 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: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• 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
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1