MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SAN JOSE INTELLAMAP ORION?; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M004RC64S0

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/08/2014

Event Type  malfunction  

Event Description

Reportable based on analysis completed on 11nov2014.It was reported that during an ablation procedure in the right atrium, the catheter was unable to be deployed.The catheter was removed and they found that there was a feature on the side of the handle that had became loose.The physician was able to complete the procedure using this device.Patient status reported as fine.Returned device analysis revealed that the safety button was completely detached.

Manufacturer Narrative

(b)(4).Visual inspection of the returned device revealed that the device safety button was loose and detached.The handle was opened and the safety button was found completely detached.There was evidence of adhesive in two points inside the component, however it is broken.The device was able to perform deploy and undeploy without issues during the dimensional test.The handle and safety button sections were sent to mtac for additional analysis to determine the failure mode.This analysis revealed adhesive failure sites presented evidence of cleavage/peel mechanical overload.In addition to adhesive failure, the safety button presented delamination and particle rich in sodium and chloride.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).

• Brand Name: INTELLAMAP ORION?
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC - SAN JOSE; 150 baytech drive; san jose CA 95134
• 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: 4251261
• MDR Text Key: 18265837
• Report Number: 2134265-2014-07369
• 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
• Report Date: 11/11/2014

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: 06/30/2015
• Device Model Number: M004RC64S0
• Device Catalogue Number: RC64S
• Device Lot Number: 17088826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2014
• Initial Date FDA Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1