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

Model Number M-4800-01

Device Problems Device Alarm System (1012); Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/03/2016

Event Type  malfunction  

Manufacturer Narrative

The 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).

Event Description

It was reported that the left atrium map shifted significantly (8 mm and more in some locations) while moving the ablation catheter from the left veins to the right veins during an afib case using carto 3 system.No errors were seen on the carto 3 system.The patient was morbidly obese, but under anesthesia and did not appear to move.All 6 patches were in range but close to maximum height.A new map was performed to continue the case.The case was completed without patient harm.This is mdr reportable as map shift without error message could potentially be caused by system malfunction and might cause a potential risk to patient.

Manufacturer Narrative

(b)(4).It was reported that during an afib case, the la map shifted significantly while moving the ablation catheter from the left veins to the right veins.No errors were seen on the c3 system.The patient was morbidly obese, but under anesthesia and did not appear to move.All 6 patches were in range but close to maximum height.A new map was performed to continue the case, completed without patient harm.Issue related to patient setup.Fse followed up with account to explain that the issue was caused by stretching of obese patient's skin and wedges placed under him.In addition fse followed up with cas again after two more cases.Issue has not occurred again.System ready for use.The history of customer complaints associated with carto 3 system # 11786 was reviewed.There was no any additional complaint out of 54 additional reported complaints that 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: 5536510
• MDR Text Key: 41777185
• Report Number: 3008203003-2016-00009
• 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: 03/03/2016

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: 03/03/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1