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 01/27/2020

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.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 mapshift issue occurred.It was initially reported by the customer caller that at the beginning of the procedure they had performed catheter visualization but moved the location pad prior to mapping.Then later during the procedure (mapping and ablation) a map shift was noted on carto system.No error codes or learn new messages were displayed.There was no report of patient consequence.On 1/29/2020, additional information was received which indicated there was no error provided by the carto® 3 system when the map shift occurred.Map shift was discovered because ablation catheter was making contact with 5-10g of force but its location was significantly different from the original fam and points collected by both pentaray and ablation catheter.There was a difference of roughly 10mm, measured using the distance measurement tool on carto® 3 system.Cardioversion has been performed but, map shift occurred prior to the cardioversion, and neither the patient nor the patches moved after mapping had begun.Location pad was moved down the table after initialization but before any points/fam had been collected.This event was originally considered non-reportable, however, bwi became aware that the map shift occurred prior to cardioversion on 1/29/2020 and re-assessed the complaint as mdr reportable.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a mapshift issue occurred.It was initially reported by the customer caller that at the beginning of the procedure they had performed catheter visualization but moved the location pad prior to mapping.Then later during the procedure (mapping and ablation) a map shift was noted on carto system.No error codes or learn new messages were displayed.There was no report of patient consequence.On 1/29/2020, additional information was received which indicated there was no error provided by the carto® 3 system when the map shift occurred.Map shift was discovered because ablation catheter was making contact with 5-10g of force but its location was significantly different from the original fam and points collected by both pentaray and ablation catheter.There was a difference of roughly 10mm, measured using the distance measurement tool on carto® 3 system.Cardioversion has been performed but, map shift occurred prior to the cardioversion, and neither the patient nor the patches moved after mapping had begun.Location pad was moved down the table after initialization but before any points/fam had been collected.Device evaluation details: the bwi field service engineer (fse) visited the account and performed preventative maintenance testing.All tests passed.The system is operational.The study data that related to the reported issue was investigated by the device manufacturer.It was found that the catheter and the chest patches experienced metal distortion caused by fluoro system position change in location pad electromagnetic field.The metal distortion caused the magnetic shift of chest patches position relatively to back patches.It affected on the body coordinate system (bcs) correction, that was not symmetric for the back and chest patches, and consequently caused to map shift.But, the level of metal distortion was below the designed warning threshold.As result, the system did not alert user about the metal distortion that could cause map shift.An internal corrective action has been opened to investigate the reported issue.A manufacturing record evaluation was performed for the system 11431, 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: 9735247
• MDR Text Key: 196562892
• Report Number: 2029046-2020-00280
• 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
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

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: 01/29/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 04/19/2020
• Supplement Dates FDA Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN ABLATION CATHETER; UNK_PENTARAY