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

Catalog Number FG540000

Device Problem Improper Device Output (2953)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/18/2017

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.This carto 3 system was manufactured before september 24, 2016.As such, udi does not apply to this product.(b)(4).

Event Description

It was reported that a patient underwent a procedure for paroxysmal atrial fibrillation with a carto 3 system where a map shift occurred.During the mapping phase of the procedure, a map shift of approximately 8 mm occurred without an associated error message.It was noted that the fast anatomical map had previously aligned with fluoroscopy and the catheter location, until the shift occurred.No cardioversion was performed, and no patient movement was noted.The study was closed and reloaded, which resolved the issue.The case then continued.No patient consequences were reported.Map shifts without an associated error message or patient movement/cardioversion can present a possible risk to the patient, making this an mdr reportable event.

Manufacturer Narrative

It was reported that there was a possible map shift, without error messages.Caller stated that the fam, fluoro, and catheter location all agreed.The physician felt that the map had shifted.Caller stated that they closed and reload study and that resolved the issues to the physician satisfaction.Procedure was continued and no patient consequences were reported.The fse followed up the issue with clinical account specialist (cas).The cas confirmed that patient had moved during the case, and issue immediately occurred after patient movement.The cas restarted study and rebooted patient interface unit (piu); cas confirmed that issue was resolved and did not reoccur for the rest of the day.System was operational.When the relative position between the patches remains the same but the position of the heart relative to the back patches has changed (for example, after repositioning the patient's head on a pillow or moving the patient's arm without changing the patient's position on the mattress, or after the patient is cardioverted), the system will not give a warning and an incorrect map (map shift) might be generated.The device history record (dhr) review 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 # (b)(4).

• Brand Name: CARTO 3
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 949789-383
• MDR Report Key: 6995224
• MDR Text Key: 91471307
• Report Number: 2029046-2017-01093
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1