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

Model Number M004RC64S0

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2014

Event Type  malfunction  

Event Description

Reportable upon analysis completed on 28nov2014.It was reported that there were deployment slider stiffness issues.An atrial fibrillation procedure was being performed in the left atrium.When undeploying an intellamap orion¿ mapping catheter, the deployment slider became very stiff in the middle of the slider range.When pulled back it was significantly less stiff.When deploying the catheter, the deployment slider was more or less uniformly stiff.The physician withdrew the catheter from the patient and verified that the device could be deployed and undeployed with adequate force, and continued to use this catheter.The ablation procedure was successful and no patient complications were reported.However, returned device analysis found the safety button detached.

Manufacturer Narrative

(b)(4).A visual inspection revealed the device safety button is detached.A functional examination found that the device curves properly and it deploys and un-deploys with no resistance.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.In addition the safety button tap was found damaged.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 - 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: 4343493
• MDR Text Key: 5137739
• Report Number: 2134265-2014-08058
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K122461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 11/28/2014

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: 07/02/2015
• Device Model Number: M004RC64S0
• Device Catalogue Number: RC64S
• Device Lot Number: 17094081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2014
• Initial Date FDA Received: 12/18/2014
• 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
• Type of Device Usage: Initial
• Removal/Correction Number: 91004680-FA
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 96