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

Model Number M004R96200

Device Problems Partial Blockage (1065); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that a tear was noted on the exterior jacket of the catheter and the tip was kinked during atrioventricular ablation in the right atrium.In addition, when the catheter was deflected, irrigation was blocked.Another catheter was used to complete the procedure and no patient complications occurred and the patient¿s condition is fine.

Manufacturer Narrative

Device evaluated by manufacturer: visual inspection of the device revealed a severe kink on the proximal side of ring 3 and a bend n the main body tubing.Dried body fluids were found on the handle, main body tubing, and o the distal end.The tension control knob functioned properly on both lock and unlock positions.The steering knob did not alter the distal end curve when turned clockwise.X-ray imaging revealed a broken center support and steering wire.The distal end was dissected and inspection confirmed the broken enter support.It has cu the kevlar wrap, puncture the sheath, and then pierced the cooling lumen.The cooling lumen¿s location above the center support prevented perforation of the main body tubing.The center support also has a bend approximately 30mm from the end of the distal tip.The right steering wire is broken at the same location as the center support, and has retracted back toward the handle.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion was unable to be determined.(b)(4).

Event Description

It was reported that a tear was noted on the exterior jacket of the catheter and the tip was kinked during atrioventricular ablation in the right atrium.In addition, when the catheter was deflected, irrigation was blocked.Another catheter was used to complete the procedure and no patient complications occurred and the patient¿s condition is fine.

• 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: 7410735
• MDR Text Key: 104851224
• Report Number: 2134265-2018-03145
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150005
• 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,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2020
• Device Model Number: M004R96200
• Device Catalogue Number: R9620
• Device Lot Number: 0021338872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2017
• 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: 50 YR