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

Model Number M-4800-01

Device Problems Issue With Displayed Error Message (2967); Material Distortion (2977)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2016

Event Type  malfunction  

Manufacturer Narrative

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.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.At the beginning of fast anatomical mapping (fam) creation in the left atrium with the a lasso catheter, a metal distortion error on the chest patch was observed.This was due to steep lao of the fluoroscopy system and closeness of the image intensifier to the chest.The ii was raised up and the error disappeared.Fam was then collected.Later in the study, no errors appeared but a small shift in the left inferior pulmonary vein (lipv) and right inferior pulmonary vein (ripv) were observed by the operator.The catheters were no longer lining with the left atrium map which they had created earlier leading them to believe that there was a map shift.The distance was the size of the variable lasso catheter loop approximately 15mm.The cause of the shift was unknown.The patient was not cardioverted.The patient could have moved but there was no indication that this had occurred.There was no delay to the procedure.The procedure was completed.There was no adverse consequence to the patient.The metal distortion error was assessed as not reportable as the most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.This map shift issue with no error message was assessed as a reportable malfunction as there is a potential risk to the patient.

Manufacturer Narrative

(b)(4).It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto 3 system.At the beginning of fast anatomical mapping (fam) creation in the left atrium with the lasso catheter, a metal distortion error on the chest patch was observed.This was due to steep lao of the fluoroscopy system and closeness of the image intensifier to the chest.The ii was raised up and the error disappeared.Fam was then collected.The issue resolved.Later in the study, no errors appeared but a small shift in the left inferior pulmonary vein (lipv) and right inferior pulmonary vein (ripv) were observed by the operator.The cause of the shift was unknown.There was no delay to the procedure.There was no adverse consequence to the patient.The biosense webster field service engineer tested the system (system passed sid test) and confirmed that the system is fully functional and ready for clinical use.The 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 (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: 5549426
• MDR Text Key: 42945228
• Report Number: 3008203003-2016-00012
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• 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
• Date Manufacturer Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1