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

Model Number M-4800-01

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2014

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a carto® 3 system and a map shift occurred.During procedure, the catheter had moved from left to right vein and was outside of the fam shell that had been previously created.The system did not provide any errors for the map shift.The physician discovered this issue when the catheter was moved into the right veins and after isolating the left side pv¿s.The issue occurred during mapping and approximately 5 ¿ 10 mm was the difference catheter location before and after map shift.The procedure was completed conventionally with another carto system with no patient consequences.As no error message occurred for map shift, this could potentially cause by system malfunction and therefore, a potential risk to patient.

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.Concomitant bwi products: product: lasso, us catalog # unknown, lot # unknown.(b)(4).

Manufacturer Narrative

Manufacturer's reference # (b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a carto® 3 system and a map shift occurred.During procedure, the catheter had moved from left to right vein and was outside of the fam shell that had been previously created.The system did not provide any errors for the map shift.The physician discovered this issue when the catheter was moved into the right veins and after isolating the left side pv¿s.The issue occurred during mapping and approximately 5 ¿ 10 mm was the difference catheter location before and after map shift.The procedure was completed conventionally with another carto system with no patient consequences.As no error message occurred for map shift, this could potentially cause by system malfunction and therefore, a potential risk to patient.The investigational analysis has been completed.The piu (patient interface unit) and lp (location pad) were replaced, bwi representative performed the functional tests and all tests passed.Suspicious piu and lp were sent to device manufacturer (htc) for investigation, the issue was investigated at bwi lab with no reproduced.The piu sent to (b)(4) lab for upgrade.The piu passed all tests and works properly.The customer complaint was not confirmed regarding map shift issue.However, it was found that piu and lp kit had an unstable communication with main card.This is not related to the reported event.A device history record review was performed by the manufacturer and no anomalies were noted in manufacturing or servicing of this equipment.Management is notified of failure analysis through the monthly trending reports.No significant trends have been identified at this time; therefore no capa activity is required.

• 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 2066 717; IS 2066717
• Manufacturer Contact: jaime chavez ; 15715 arrow highway; irwindale, CA 91706 ; 9098398483
• MDR Report Key: 4243563
• MDR Text Key: 5109514
• Report Number: 3008203003-2014-00074
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• 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: 10/27/2014

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2014
• Initial Date FDA Received: 11/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1