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

Model Number M-4800-01

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 05/29/2014

Event Type  malfunction  

Event Description

It was reported that a patient (b)(6) years old, female, underwent an atrial fibrillation (afib) procedure with a carto 3, and a carto/noga application issue/error message and procedure cancellation device malfunction occurred.There were loop of the errors 1-2-3 after turning on the system.The issue occurred before starting an af.Also there was error # 17 on the carto system: location pad current unstable.The patient was under local anesthesia.The procedure was being performed in the left atrium and a transseptal puncture performed.There was no patient consequence.The patient required extended hospitalization because of this issue.The procedure was rescheduled.The physician did not consider cancelling the procedure caused a potential risk to this patient.Per 21 cfr, part 803, this complaint is reportable because device malfunction of this type could potentially contribute to a death or serious injury.Investigation is still in progress.A supplemental report on device evaluation will be submitted.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Refer to evaluation summary: manufacturer ref # (b)(4).It was reported that there were loop of the errors 1-2-3 after turning on the system.The issue occurred before starting an af.Also there was error # 17 on the carto system: location pad current unstable.The procedure was rescheduled.After switching off the system, the customer realized that the location pad extension cable is bent on the back of the piu.The cable is also a little unscrewed.The customer disconnected the cable and discovered that at least three pins inside the cable connector are bent.The location pad extension cable replaced.The system is ready to use.A dhr review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment." in addition, a corrective action has been opened to address and resolve this issue.

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL); 4 hatnufah st.; yokneam 20692 ; IS 20692
• Manufacturer (Section G): BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL); 4 hatnufah st.; yokneam 2069 2; IS 20692
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3854720
• MDR Text Key: 20784889
• Report Number: 3008203003-2014-00041
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K090017
• 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: 05/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• 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: 05/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 60 YR