MAUDE Adverse Event Report: BIOSENSE WEBSTER (ISRAEL) LTD. CARTO® 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number M-4800-01

Device Problems Migration or Expulsion of Device (1395); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/12/2016

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.(b)(4).

Event Description

It was reported that a patient underwent an ablation procedure for focal atrial tachycardia with a carto 3 system and a map shift with no error message occurred.The right atrium and aortic root had both been mapped for early activation over a period of 90 minutes.It was noted that the diagnostic his catheter and coronary sinus catheter had both moved superiorly and posteriorly as compared to the snapshot.It was concluded that there had been a map shift which was not noted by the system.There was no error message displayed on the carto 3 system when the map shift occurred.The map shift was visually obvious.The approximate difference in catheter location before and after map shift was 5mm.No cardioversion was performed.The patient was awake and may have moved slightly although the physician does not believe this was the case as no patient movement was observed.A second geometry of the aortic root was created after the map shift and prior to ablation of the earliest site of activation in the aortic root.There was a 10 minutes delay to the procedure.The procedure was subsequently completed with no patient consequence.This event is mdr reportable because map shifts with no errors or patient movements could lead to a potential risk to the patient.

Manufacturer Narrative

Due to the august 2015 fda maintenance where the 3500a codes were updated, the 3500a codes ( evaluation codes) will be added until the biosense webster system is also updated.Therefore the following codes apply: (b)(4).It was reported that a patient underwent an ablation procedure for focal atrial tachycardia with a carto 3 system and a map shift with no error message occurred.No further map shifts have been observed since this complaint was reported.No further service was requested.The system is ready for use.The device history record review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• 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 ; 9497893837
• MDR Report Key: 5631949
• MDR Text Key: 45376301
• Report Number: 3008203003-2016-00014
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M-4800-01
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1