MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (HEREDIA) INTELLANAV OI

Model Number	M004R9620K20
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that catheter separation occurred.During an ablation procedure, the intellanav oi ablation catheter showed high temperatures during use; high temperature errors were displayed on the maestro generator.Upon removing the catheter from the patient, it was discovered that the distal shaft section had become separated from the proximal shaft section.The procedure was completed using another catheter.There were no patient complications.
Additional Manufacturer Narrative
Updated: device evaluated by mfr., eval summary attached, method codes, results codes, conclusion codes.Device evaluated by mfr: returned device analysis found a gap of approximately 1mm at the butt bond between the insulations of the distal and proximal shafts.Subsequent body fluid ingress due to the gap was most likely the reason for the high temperature errors.Electrical testing found no open circuits and thermocouple measurements were within specification.Measurements between the thermocouple, the magnetic sensor, and the electrodes were erratic, which was also most likely due to fluid ingress.Ablation was verified using a maestro generator; after two seconds of ablation the maestro displayed a d05 (excessive temperature) error and the ablation was halted.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is design specification as the device problem was traced back to the design specifications.(b)(4).
Event or Problem Description
It was reported that catheter separation occurred.During an ablation procedure, the intellanav oi ablation catheter showed high temperatures during use; high temperature errors were displayed on the maestro generator.Upon removing the catheter from the patient, it was discovered that the distal shaft section had become separated from the proximal shaft section.The procedure was completed using another catheter.There were no patient complications.

• Brand Name: INTELLANAV OI
• Common Device Name: INTELLANAV OI
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (HEREDIA); 302 parkway; la aurora; heredia ; CS
• MDR Report Key: 7230161
• Report Number: 2134265-2018-00195
• Device Sequence Number: 957422
• Product Code: OAE
• UDI-Device Identifier: 08714729937449
• UDI-Public: 08714729937449
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P150005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/08/2020
• Device Model Number: M004R9620K20
• Device Catalogue Number: R9620K2
• Device Lot Number: 21232041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Initial Date Received by Manufacturer: 01/03/2018
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 02/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1