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

Model Number M-4800-01

Device Problem Radio Signal Problem (1511)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/04/2015

Event Type  malfunction  

Event Description

It was reported that during an atrial fibrillation (afib) procedure, at the end of the cryo the physician put in an ablation catheter and mapped both atria.Then the physician started the ablation, the signal loss was observed on all ecg (bs + ic) channels on both carto 3 system and recoding system.The issue did not resolve by rebooting the workstation and changing the ablation cable.The procedure was completed without the carto 3 system without any patient consequence.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).It was reported that during an atrial fibrillation (afib) procedure, at the end of the cryo the physician put in an ablation catheter and mapped both atria.Then the physician started the ablation, the signal loss was observed on all ecg (bs + ic) channels on both carto 3 system and recoding system.The issue did not resolve by rebooting the workstation and changing the ablation cable.The procedure was completed without the carto 3 system without any patient consequence.Biosense field service engineers were unable to duplicate the reported issue.They did not notice any bent pins on the ports.Biosense field service engineers performed a wet bath ablation.The system displayed all body surface and ic signals.An acceptance testing was performed on the carto 3 system.All required tests passed and the system is ready for use.The complaint was not confirmed.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
• Manufacturer Contact: jaime chavez ; 9098398483
• MDR Report Key: 4633095
• MDR Text Key: 18269096
• Report Number: 3008203003-2015-00014
• 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: 03/04/2015

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: 03/04/2015
• Initial Date FDA Received: 03/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1