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

Model Number M-4800-01

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 05/16/2016

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 atrioventricular nodal reentrant tachycardia (avnrt) procedure with a carto 3 system.During the procedure and post ablation, two separate map shifts were noted during the procedure.The maps were noted to have shifted about 7mm.On the location set up, the patches were all within range.The patient had not moved.A cardioversion was not performed prior to the map shift.Metal values were within normal limits at the time of the call.The system provided no errors.The procedure continued with no patient consequence.This map shift with no error or warning message displayed was assessed as a reportable malfunction as there was no patient movement or cardioversion.Therefore, no error populating can potentially pose a risk to the patient.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a carto 3 system.During the procedure and post ablation, two separate map shifts were noted during the procedure.The maps were noted to have shifted about 7mm.On the location set up, the patches were all within range.The patient had not moved.A cardioversion was not performed prior to the map shift.Metal values were within normal limits at the time of the call.The system provided no errors.The procedure continued with no patient consequence.The biosense webster field service engineer followed up with the account.The problem was not duplicated in the last 4 cases.The customer declined service when contacted by biosense webster field service engineer.System is operational.The device history record (dhr) 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: 5723823
• MDR Text Key: 48414533
• Report Number: 3008203003-2016-00022
• 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: 05/16/2016

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: M-4800-01
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/16/2016
• Initial Date FDA Received: 06/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1