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

Model Number M004EPTR9620N40

Device Problem Device Sensing Problem (2917)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: visual inspection revealed dried body fluids on the handle, main body tubing and on the distal end.The distal end has twisted spiral marks in the main body tubing.Rings 1, 2 & 3 were partially flattened by some sort of tool.Tool marks can be seen on rings 2 & 3.Body fluid found under the edge of ring 1.Electrical continuity checks revealed no electrical shorts.Electrical opens were found for ring 1, ring 2 and magnetic sensor.The steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.X-ray found twisted electrical wires and a broken ring 1 wire.The distal end was dissected.Ring 1 and ring 2 wires were broken at the rings.As viewed from the end of the tip, the electrical wires, center support, steering wires and irrigation tube had been severely twisted in the counter-clockwise direction.The magnetic sensor insulation was dissected.The sensor wire was broken.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is user / use error as there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer or expected by the user, due to torsional overstress and tooling marks.(b)(4).

Event Description

Reportable based on device analysis completed on 21feb2018.It was reported that an intellanav oi was selected for a radiofrequency ablation.During the procedure catheter was not visible on rhythmia and there were no egms both on cardiolab system and on rhythmia system.On the rhythmia there was an error message saying the magnetic sensor was broken or disconnected.The procedure was completed with another intellanav oi.The patient was reported to be in stable condition.However; returned device analysis revealed a damaged and compromised electrode seal.

• Brand Name: INTELLANAV OI
• Type of Device: INTELLANAV OI
• 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: 7361179
• MDR Text Key: 103295363
• Report Number: 2134265-2018-02259
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2020
• Device Model Number: M004EPTR9620N40
• Device Catalogue Number: EPTR9620N4
• Device Lot Number: 20463747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2017
• 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: 41 YR