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 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

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 map shift occurred.No errors were reported by the carto® 3 system.The map shift (~5cm) was visually discovered by the physician during a mapping.The map did not correspond to the one made initially.No cardioversion prior to catheter shift, nor patient movement.There was no patient consequence.

Manufacturer Narrative

It was reported that a patient underwent cardiac ablation procedure with a carto® 3 system where map shift occurred.No errors were reported by the carto® 3 system.The map shift (~5cm) was visually discovered by the physician during a mapping.The map did not correspond to the one made initially.No cardioversion prior to catheter shift, nor patient movement.There was no patient consequence.Device evaluation details: the device evaluation has been completed.A biosense webster inc.(bwi) field service engineer (fse) visited the account.Test plans were performed with no solution.The customer requested a patient interface unit (piu) replacement due to issue reoccurrence.The piu and location pad (lp) kit was replaced and sent to the device manufacture for investigation and repair, where the map shift issue was not confirmed.During the investigation process, other defects were found such as damaged pins in the different piu connectors, damaged slot for the ecg card, defective mag tx card and damaged connector on the lp cable.However, all the defects found were not related to the reported map shift issue and could not cause a map shifts.After this complaint, the same map shift issue was reported again after the piu/lp kit replacements which indicate the map shifts were not carto 3 system related.Based on available study data from another reported map shift case, 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 system did not alert user about the metal distortion that could cause map shift.The source of the metal on the catheter is not clear as the patch metal levels were quite low and stable.However, performing the acquire action under significantly different metal levels create nonconsistency in the map known as map shift.Its been reported that 2 months after the last map shift issue, the issue has not reoccurred.The system is operational.This issue was found to be a software problem and traced to environment.An additional issue is not related to the map shift complaint was also reported: during the fse¿s visit the pin box was found damaged.Replacement pin box was provided to the account.The issue resolved.The system is operational.This issue was determined to be a mechanical problem traced to component failure.A manufacturing record evaluation was performed for the carto 3 system s/n (b)(6), and no internal actions 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).

• 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: 10764151
• MDR Text Key: 228032506
• Report Number: 2029046-2020-01604
• 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: 10/12/2020

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: 10/12/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 12/29/2020
• Supplement Dates FDA Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1