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 Consequences Or Impact To Patient (2199)

Event Date 04/06/2017

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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.While mapping during the procedure, a shift of between 0.5cm to 2cm in the catheter position on univu was reported with the use of the carto 3 system.The procedure was completed with no patient consequence.The response received confirms that there was no error message or patient movement prior to the shift.This event has been assessed as a reportable malfunction as such map shifts could potentially be caused by a system malfunction, and there could be a potential risk to the patient.

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.While mapping during the procedure, a shift of between 0.5cm to 2cm in the catheter position on univu was reported with the use of the carto 3 system.The procedure was completed with no patient consequence.The response received confirms that there was no error message or patient movement prior to the shift.The biosense webster field service engineer followed up on the issue with the account.The biosense webster field service engineer confirmed that the map miss alignment (map shift) happened regarding fluoroscopy settings.Settings were corrected.Miss alignment issue was resolved.System is working according to its specifications and ready for clinical use.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.

• 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: 6524527
• MDR Text Key: 74052941
• Report Number: 3008203003-2017-00021
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• 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: 04/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1