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 09/05/2019

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture reference no: (b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for atrial fibrillation with the carto® 3 system and a map shift error occurred.At the beginning of the procedure the patient interface unit (piu) displayed contact force sensor error 106.The cable was changed from the piu, but the problem persisted.Replacement of the unk_smart touch bidirectional sf catheter resolved the issue.During ablation, after drug administration, the map shifted about 1.5 cm.Software version 6 was in use.The observed contact force sensor error 106 has been assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The observed map shift has been assessed as an mdr reportable malfunction as map shifted with no error message, patient movement, or cardioversion.

Manufacturer Narrative

It was reported that a patient underwent an ablation procedure for atrial fibrillation with the carto® 3 system and a map shift error occurred.At the beginning of the procedure the patient interface unit (piu) displayed contact force sensor error 106.The investigational analysis completed (b)(6)2019.The system was checked by technical services and found to be fully operational.The field service engineer (fse) explained to the lab and team how carto system behaves when sedation is provided to the patient.The fse followed up, and was advised that several cases have been performed after the reported issue without map misalignment.The system is fully operational.A manufacturing record evaluation was performed for the finished device and no internal actions were found during the review.Manufacture reference no: (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: 9142702
• MDR Text Key: 164241004
• Report Number: 2029046-2019-03708
• 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: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000
• Date Manufacturer Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THMCL SMTCH SF UNID, TC, F