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

Model Number M-4800-01

Device Problem Computer Operating System Problem (2898)

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

Event Date 05/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It was reported that a map shift occurred during a procedure.User couldn't find the right position of the vein and she had to use fluoroscopy to know the exact position of the catheter.Case completed with no patient consequence.Issue was related to system behavior.As describe in ifu (v4 section on chapter 2) when the relative position between the patches remains the same but the position of the heart relative to the back patches has changed the system will not give a warning and an incorrect map (map shift) might be generated.The sedation to the patient during the case was causing a movement of the hearth related to the back patches and this was clearly evident by the analysis of the patches position through the extended features.Avoiding sedation peaks during the case solved the issue.The issue did not occured the following cases.System was ready for use.The history of customer complaints associated with carto 3 system # 50119 was reviewed.Two (2) out of 25 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.

Event Description

It was reported that a map shift occured during the procedure.The procedure was completed without patient consequence using fluoroscopy to visualize the catheter.No other information was available.This is information by itself is not assessable for reportability.Additional information received on 05/26/2016 clarifies the circumstances in which the map shift occurred, and quantifies the amount of catheter displacement caused by the shift: the map shift was approximately 6-12 mm and carto did not display any error messages.Cardioversion had not been performed, and no patient movement had been noted at the time the map shift was discovered.This issue is mdr reportable as such map shifts could potentially be the result of system malfunction, and there is a potential risk to patient.This clarification of the initial event description provides us the information necessary to classify this event as possibly reportable, and thus the alert date has been changed 5/26/2016.

• 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 ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 5737287
• MDR Text Key: 48724040
• Report Number: 3008203003-2016-00026
• 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
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2016

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2016
• Initial Date FDA Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1