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

Model Number M004RC64S0

Device Problems Bent (1059); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2014

Event Type  malfunction  

Event Description

T was reported that the safety button was not attached.Mapping was performed in the left ventricular outflow tract (lvot) with the intellamap orion¿ catheter.The physician commented that the anatomy of the aorta was very small, the orion was curved 180 degrees but was not able to go back to 0 degrees due to the small anatomy of the aorta.During the approximately 50min long procedure it was noted that the "control deployment lock button" popped out of place.The safety button was replaced onto its appropriate seating position and the catheter was un-deployed and removed from the patient.No patient complications were reported.

Manufacturer Narrative

Device evaluated by manufacturer - the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Manufacturer Narrative

Device evaluated by manufacturer - the device is bent at the distal section.Also, the safety button is detached.The device passes the curving and out-of-plane test.The device deploys and un-deploys as expected.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 and the handle cover inner side were 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).

Event Description

It was reported that the safety button was not attached.Mapping was performed in the left ventricular outflow tract (lvot) with the intellamap orion catheter.The physician commented that the anatomy of the aorta was very small, the orion was curved 180 degrees but was not able to go back to 0 degrees due to the small anatomy of the aorta.During the approximately 50min long procedure it was noted that the "control deployment lock button" popped out of place.The safety button was replaced onto its appropriate seating position and the catheter was un-deployed and removed from the patient.No patient complications were reported.

• 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: 4249537
• MDR Text Key: 5014481
• Report Number: 2134265-2014-07209
• 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,Followup
• Report Date: 11/05/2014

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: 08/18/2015
• Device Model Number: M004RC64S0
• Device Catalogue Number: RC64S
• Device Lot Number: 17208445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2014
• Initial Date FDA Received: 11/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2014
• 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: 63 YR
• Patient Weight: 68