MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) 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 11/10/2014

Event Type  malfunction  

Event Description

It was reported that the safety button was not attached.The "button" on the intellamap orion¿ catheter came away from the handle when the button was facing towards the ground (gravity).This prevented the catheter deployment mechanism from un-deploying the catheter.This was resolved by pushing the button back in, which allowed the catheter deployment mechanism to work again.The procedure was completed with this device.No patient complications occurred.

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).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 mfr: - the unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned device matches with upn provided by the customer.The device does not have visual defects and the safety button is not detached.The device passes the deployment/un-deployment test.The handle was opened and the safety button was not found detached.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The most probable root cause is: not confirmed.The returned sample was visually inspected, finding no visual defects and the safety button is not detached.(b)(4).

Event Description

It was reported that the safety button was not attached.The "button" on the intellamap orion catheter came away from the handle when the button was facing towards the ground (gravity).This prevented the catheter deployment mechanism from un-deploying the catheter.This was resolved by pushing the button back in, which allowed the catheter deployment mechanism to work again.The procedure was completed with this device.No patient complications occurred.

• 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 - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4250623
• MDR Text Key: 5046764
• Report Number: 2134265-2014-07367
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 11/10/2014

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: M004RC64S0
• Device Catalogue Number: RC64S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2014
• 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
• 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