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

Model Number M004RC64S0

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the catheter was received for analysis after decontamination (in appropriate packaging).The returned device matches the upn and lot number provided by the customer.Visual inspection found spline #4 was bent at the proximal end of the array upon deployment.Upon further examination using the nikon microscope, the spline appeared to be cracked in the middle of the spline.The electrical test was performed and the device failed the test.The device passed the magnetic tracking test.There were 29 opens discovered during the electrical test.Magnetic sensor resistance test was performed, and the device was found to be within specification.Upon x-raying the device, no evidence of open wires was found.The manufacturing batch record review confirmed that the device met all material, assembly and performance specification.Complaint confirmed.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

Reportable based on device analysis completed on 25apr2017.It was reported the catheter experienced electrical noise during an animal study.During the study, using the intellamap orion catheter, there was an increasing number of electrodes showing electrical noise.It became impossible to continue mapping due to the amount of noise experienced.Troubleshooting was performed to re-condition the catheter, which was unsuccessful.The procedure stopped and was not completed due to this event.No patient complications were reported.However, device analysis found spline 4 of the catheter cracked.

• Brand Name: INTELLAMAP ORION¿
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6577491
• MDR Text Key: 75518867
• Report Number: 2134265-2017-04606
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K122461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2017
• Device Model Number: M004RC64S0
• Device Catalogue Number: RC64S
• Device Lot Number: 19617273
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2016
• 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