MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) INTELLAMAP ORION?; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M004RC64S0

Device Problems Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2014

Event Type  malfunction  

Event Description

It was reported that the safety button was not attached.During a mapping procedure in the left atrium the physician was unable to undeploy the intellamap orion mapping catheter.The bsc mapping specialist recognized that the safety button was popped out.After pushing the button back in the physician was able to undeploy the basket.This issue occurred 3 times and each time they pushed the button back in.The physician also noted that the ability to get the catheter into the right inferior pulmonary vein was quite difficult.The physician completed the procedure with this device.No patient complications were reported and the patient¿s status was fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer: a visual examination identified the safety button detached.The device passe the deployment/un-deployment test.The handle was opened and the safety button was found completely detached.There is evidence of adhesive in two points inside the component, however it is broken.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

It was reported that the safety button was not attached.During a mapping procedure in the left atrium the physician was unable to undeploy the intellamap orion mapping catheter.The bsc mapping specialist recognized that the safety button was popped out.After pushing the button back in the physician was able to undeploy the basket.This issue occurred 3 times and each time they pushed the button back in.The physician also noted that the ability to get the catheter into the right inferior pulmonary vein was quite difficult.The physician completed the procedure with this device.No patient complications were reported and the patient's status was fine.

• Brand Name: INTELLAMAP ORION?
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4249833
• MDR Text Key: 4989799
• Report Number: 2134265-2014-07366
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• 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 Expiration Date: 09/05/2015
• Device Model Number: M004RC64S0
• Device Catalogue Number: RC64S
• Device Lot Number: 17258617
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2014
• Initial Date FDA Received: 11/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1