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

Model Number M-4800-01

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a carto 3 system and experienced issues of system performance and communication with the patient interface unit (piu), therefore procedure was cancelled since the procedure could not be finished without the carto3.Patient was under general anesthesia and transseptal puncture was performed prior to cancelling the procedure.There was no patient consequence.However per 21 cfr, part 803, this complaint is reportable because an event of this type could contribute to a serious injury.

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).

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a carto 3 system and experienced issues of system performance and communication with the patient interface unit (piu), therefore procedure was cancelled since the procedure could not be finished without the carto3.Patient was under general anesthesia and transseptal puncture was performed prior to cancelling the procedure.The investigational analysis has been completed.Lp extension cable replacement and proper booting of the system solved the issue.The system ready for use.The same issue occurred and reported under pi1-pctazu.Piu, lp, and pu were replaced.The replaced parts were sent to htc for investigation.(rma# 10074).Htc tested the parts and confirmed the problem.Shorted two pins of diode array of backplane caused the problem.The backplane was sent to subcontractor for repair.The history of customer complaints associated with carto 3 system # r10015 was reviewed.Out of 50 additional reported complaints there were 4 additional complaints that may be related to the reported issue.A 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 2066 717; IS 2066717
• MDR Report Key: 4272311
• MDR Text Key: 5224310
• Report Number: 3008203003-2014-00077
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2014

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2014
• Initial Date FDA Received: 11/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2015
• 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