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 05/31/2019

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.Manufacturer's ref # (b)(4).

Event Description

It was reported a patient underwent an atrial tachycardia (at) procedure with a carto 3 system and a map shift issue occurred.It was initially reported that during the mapping phase of an atrial tachychardia ablation procedure, an issue happened with software version 7.When attempting to collect data from one map, the map suddenly shifted around 3 cm.The issue was resolved by re-mapping.No delays reported.There were no patient consequences.The map shift issue was initially considered non-reportable since there was no information regarding possible cardioversion or patient movement.On 6/3/2019, additional information was received indicating that no error messages were displayed.Map shift discovered after doing a remap of a parallel map.Comparing both maps showed a displacement between both maps.The approximate difference in catheter location before and after the reported map shift was reported as 3.50 mm (measured 2 identical locations using "distance measurement tool").It was also reported that the physician did not perform cardioversion prior to the map shift and there was no patient movement.A software bug was suspected.This event was originally considered nonreportable, however, based on the additional information received on 6/3/2019, the event has been reassessed as mdr reportable as a malfunction since information was received indicated that no error messages were given by the system, the physician did not perform cardioversion prior to the map shift and there was no patient movement.

Manufacturer Narrative

On 6/25/2019, an error was found in the initial 3500a mdr report submitted to fda.Usage of device was reported incorrectly "initial use of device" and it should have been reported as "reuse".Manufacturer's ref # (b)(4).

Manufacturer Narrative

It was reported a patient underwent an atrial tachycardia (at) procedure with a carto 3 system and a map shift issue occurred.It was initially reported that during the mapping phase of an atrial tachychardia ablation procedure, an issue happened with software version 7.When attempting to collect data from one map, the map suddenly shifted around 3 cm.The issue was resolved by re-mapping.No delays reported.There were no patient consequences.On 6/3/2019, additional information was received indicating that no error messages were displayed.Map shift discovered after doing a remap of a parallel map.It was also reported that the physician did not perform cardioversion prior to the map shift and there was no patient movement.Device evaluations details: the device evaluation has been completed.The biosene webster inc.(bwi) field service engineer (fse) confirmed that the reported issue was resolved by re-map, system is operational and no service requested by customer.However, the data related to the reported issue was provided to device manufacturer for further investigation.The issue was further investigated and determined the issue was related to a software defect.An internal corrective action has been opened to investigate the issue.A manufacturing record evaluation (mre) 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 # pc-000473230.

• 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: 8730628
• MDR Text Key: 150164366
• Report Number: 2029046-2019-03317
• 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: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1