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

Model Number FG540000

Device Problems Display or Visual Feedback Problem (1184); Image Orientation Incorrect (1305); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2020

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.(b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure with a carto3 system where a map shift issue occurred.During carto procedure noticed a map shift of 3-4 centimeters during the procedure.No noise observed on bs ecg during ablation.There was no error message.Clear mismatch between the catheter position on the screen related to the map.This had been confirmed also by the fluoroscopy.The issue was observed during both mapping and ablating.No cardioversion performed.Patient moved without any error notified, but a similar shift 2-3cm was observed even before his movement.

Manufacturer Narrative

On (b)(6),2020, the date of event was reported to be (b)(6), 2020.As such, field "b3.Date of event" has been populated with the date.A manufacturing record evaluation was performed for the finished device 001394 number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent cardiac ablation procedure with a carto3 system where a map shift issue occurred.Device investigation details: the study data was requested by the device manufacturer to investigate the issue.However, no additional data was received from the account.Investigation of the map shift issue during the reported case was not possible.As such, the complaint history of the system was reviewed and it was found that the issue occurred again several time and was investigated subsequently investigated.It was found that the user mapped with the catheter at high alternating metal levels, these metal levels were near the designed warning threshold and the carto 3 system did not alert the user about the metal distortion that could cause a map shift.The field service engineer (fse) confirmed that 2 months after the last reported map shift, the issue has not returned.The system is operational.The field service engineer (fse) also found some bent pins in the map and ref deca ports.A piece of cable connector was found in the rf port.The pins were straightened, and the piece was removed.All acceptance testing procedure (atp) tests passed successfully.This issue of connector/port problem is not considered to be mdr reportable since the potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.A manufacturing record evaluation was performed for the finished device 001394 number, and no internal action related to the complaint was found during the review.An internal corrective action has been opened to investigate map shift issues.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: 10763002
• MDR Text Key: 230708717
• Report Number: 2029046-2020-01601
• 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,Followup
• Report Date: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• 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: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NGEN GENERATOR; UNKNOWN CATHETER