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

Model Number M-4800-01

Device Problems Break (1069); Over-Sensing (1438); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2015

Event Type  malfunction  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.(b)(6).Manufacturer's ref.No: (b)(4) the hardware investigation has begun but it has not been completed at this time.

Event Description

It was reported that during a afib ablation procedure, the right arm ecg lead was broken and did not attach securely to the ecg patch on the patient, which caused noise on both carto and recording system.All leads were affected so the physician had no ecg signals available to monitor patient heart rhythm.No patient consequence was reported.This event is being reported because lack of continuous monitoring of a patient's heart rhythms increases risk to patient.

Manufacturer Narrative

(b)(4).It was reported that the right arm ecg lead was broken and could not be attached securely to the ecg patch on the patient.This caused a noise during rf.Customer requested replacement bs ecg cable.Replacement bs ecg cable was sent to the account.Fse confirmed with cas that the replacement cable was received, installed and the reported issue is resolved.System is operational.The history of customer complaints associated with carto 3 system # 13275 was reviewed.6 out of 31 additional reported complaints may be related to the reported issue.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 20667 17; IS 2066717
• Manufacturer Contact: joaquin kurz ; 9497893837
• MDR Report Key: 5184743
• MDR Text Key: 30252348
• Report Number: 3008203003-2015-00087
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/06/2015

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2015
• Initial Date FDA Received: 10/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1