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

Model Number M-4800-01

Device Problems Loss of Power (1475); Device Stops Intermittently (1599); Device Displays Incorrect Message (2591); Noise, Audible (3273)

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

Event Date 01/19/2015

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure with a carto 3 system and the procedure was delayed for 45 minutes and had to be cancelled due to noise issues.During the case, the physician experienced intermittent signal saturation from the carto that was then followed by complete loss of signal.Metal interference errors were also prominent during the case.The procedure was aborted after 45 minutes of troubleshooting.There was no patient consequence.The physician did not provide an opinion regarding the risk to the patient.We are reporting this event of procedural delay and cancellation because the patient experienced a delay of 45 minutes while under general anesthesia and after receiving a transeptal puncture.

Manufacturer Narrative

Concomitant products: thermocool catheter (lot# 17054105m) stockert generator (serial# (b)(4)) (b)(6).Manufacture¿s reference no.: (b)(4).The product has not been returned for analysis.The product investigation is pending.

Manufacturer Narrative

Manufacturer's ref no: (b)(4).It was reported that a patient underwent an ablation procedure with a carto 3 system and the procedure was delayed and had to be cancelled due to noise issues.During the case, the physician experienced intermittent signal saturation from the carto that was then followed by complete loss of signal.Metal interference errors were also prominent during the case.This event of procedural delay and cancellation was mdr reported because the patient experienced a delay of 45 minutes while under general anesthesia and after receiving a transeptal puncture.The hardware investigation revealed that the carto main card was faulty.The customer¿s patient interface unit (piu) and location pad (lp) were replaced; the noise issue was resolved.The system is ready for use.The customer complaint was confirmed.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 2066 717; IS 2066717
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 2066 717; IS 2066717
• Manufacturer Contact: jaime chavez ; 9098398483
• MDR Report Key: 4485830
• MDR Text Key: 17690336
• Report Number: 3008203003-2015-00003
• 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: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• 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
• Date Manufacturer Received: 01/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1