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

Model Number M-4800-01

Device Problems Device Inoperable (1663); Positioning Problem (3009)

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

Event Date 05/15/2014

Event Type  malfunction  

Event Description

It was reported that a patient, underwent a atrioventricular reentrant tachycardia (avrt)/(wpw) procedure with the carto 3 system, and a map shift -no error message device malfunction occurred.The map shift occurred after the head of fluoroscopy was moved during the transseptal access before ablation.The physician noticed that the map shift occurred altering the coronary sinus fam map and the coronary sinus catheter icon only.The other maps appeared normal.No errors were present.The map shift was approximately 15mm.The acl function was turned on during the procedure.There was no cardioversion and also no patient movement noticed.The reference patch did not move or get loose before the map shift.The procedure was continued with noting the new coronary sinus catheter position.The webster coronary sinus bi-directional auto id catheter was connected to the ref port.There was no patient consequence.The procedure was completed successfully.Per 21 cfr, part 803, this complaint is reportable because device malfunction of this type could potentially contribute to a death or serious injury.The hardware 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.

Manufacturer Narrative

Investigation still in progress.A supplemental report or device evaluation will be submitted.(b)(4).

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).It was reported that a patient, underwent a atrioventricular reentrant tachycardia (avrt)/(wpw) procedure with the carto 3 system, and a map shift -no error message device malfunction occurred.The map shift occurred after the head of fluoroscopy was moved during the transseptal access before ablation.The physician noticed that the map shift occurred altering the coronary sinus fam map and the coronary sinus catheter icon only.The other maps appeared normal.No errors were present.The map shift was approximately 15mm.The acl function was turned on during the procedure.There was no cardioversion and also no patient movement noticed.The reference patch did not move or get loose before the map shift.The procedure was continued with noting the new coronary sinus catheter position.The webster coronary sinus bi-directional auto id catheter was connected to the ref port.There was no patient consequence.The procedure was completed successfully.The data related to the issue was sent to the device manufacturer and was analyzed by the responsible engineer.Issue determined to be related to clinical workflow.The device manufacturer advised that the coronary sinus catheter had moved from high density cpm to low density cpm, resulting in the apparent location discrepancy.The device manufacturer advised building hd cpm in the coronary sinus area by a sensor-based catheter and the use of accuresp module to gain the patient respiration.Site visit with further explanations by the bwi field representative /bwi field service engineer was recommended.Basing on the investigation results and workflow used by the site, the system is fully operational and works within the specs, thus no error/ warning message should be shown to the user in this case.The bwi field service engineer provided recommendations and results of the device manufacturer investigation to the bwi field representative.There have been no further issues with the coronary sinus catheter visualization since the reported issue.The bwi field representative will advise the customer and call back if any additional issues occur.The system is ready for use.A device history record (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, LTD (HAIFA, ISRAEL); 4 hatnufah st.; yokneam 20692 ; IS 20692
• Manufacturer (Section G): BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL); 4 hatnufah st.; yokneam 2069 2; IS 20692
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 3863639
• MDR Text Key: 4508513
• Report Number: 3008203003-2014-00043
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090017
• 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: 05/16/2014

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: 05/16/2014
• Initial Date FDA Received: 06/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1