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

Model Number M004RC64S0

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the returned device was reported for error 1205 ¿replace the named device¿.The reported failure was confirmed through cis analysis, with the following results: visual inspection shows the deployment shaft is separated from the deployment array.This is consistent with overload force.Electrical testing was performed and the device failed the test.Magnetic sensor resistance and inductance testing revealed both pairs are within specification.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is manufacturing execution error as the manufacturing process was not executed as validated/as designed.(b)(4).

Event Description

Reportable based on returned device analysis completed 30-mar-2018.Same case as mdr id 2134265-2016-12100.It was reported that an error code occurred.The procedure was indicated due to atria flutter.The target locations were the left and right atria.A intellamap orion¿ was selected; however, the mapping system gave error code 1205 "the following device(s) have expired".The device was exchanged for another of the same catheter.The image on the rhythmia system began flashing and the catheter was not being tracked by the system and was exchanged for another of the same device.During insertion through a sheath, one of the splines bent and broke.The device was exchanged for another of the same catheter and the procedure was completed.No patient complications nor patient injury were reported.The patient was discharged.However, returned device analysis revealed the deployment shaft is separated from the magnetic sensor array.

• 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): ARDEN HILLS, MN; 4100 hamline avenue; st. paul MN 55112
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7399339
• MDR Text Key: 104610834
• Report Number: 2134265-2018-03323
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2018

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: 11/23/2016
• Device Model Number: M004RC64S0
• Device Catalogue Number: RC64S
• Device Lot Number: 18658513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2015
• 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
• Patient Age: 80 YR