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

Model Number	M004R9620K20
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: visual inspection reveled that the distal end is severely twisted, especially immediately distal from the butt bond.The twist has clockwise rotation as viewed from the end of the distal tip.Body fluid ingress through damaged seals at the butt bond.Body fluid also seeped underneath both ring 1 seals.Dried body fluids were found on the handle, main body tubing, and on the distal tip.The luer fitting was cracked.The tension control knob functioned properly on both lock and unlock positions.The steering knob had very high resistance and could not be turned in either direction.Also, the distal end could not be curved in either direction, so curve tests could not be performed.Continuity checks revealed no electrical shorts or opens.-ray found spiraled wires at the distal end and collapsed guide coil at the weld to the center support.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user.The intellanav oi dfu ((b)(4)) states: "warnings: ¿ at no time should an intellanav¿ oi catheter be advanced or withdrawn when resistance is felt, without determining the cause.Valve damage, vascular and/or cardiac perforation is a risk with any intracardiac catheter.¿ catheter entrapment within the heart or blood vessels is a possible complication of cardiac ablation procedures.The potential for catheter entrapment may be increased when the catheter is over-torqued and/or positioned in the chordae tendineae.The occurrence of this complication may necessitate surgical intervention and/or repair of injured tissue and/or valve damage.¿ excessive curves or kinking of the catheter may damage internal wires and components, including the cooling lumen.This damage may affect steering performance and may cause patient injury.¿ manual bending and/or twisting of the distal curve can damage the steering mechanism and cooling lumens and may cause catheter failure and patient injury." and "precautions: ¿ the intellanav oi catheter is highly torquable.Avoid over-torquing.Over-rotating the handle and catheter shaft may cause damage to the distal tip or catheter assembly.Do not rotate the handle and catheter shaft more than one and one-half times the full rotation (540°).If the desired catheter tip position is not achieved, adjust the catheter¿s curve to disengage the catheter tip from the heart wall before resuming rotation of the handle and catheter shaft".(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 20june2018.A intellanav oi was selected for a 3d complex electrophysiology procedure.It was reported that catheter kinking and navigation failure occurred.No patient complications were reported.However analysis reveled seal break and butt bond failure.

• 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: 7677559
• Report Number: 2134265-2018-06067
• Device Sequence Number: 1553693
• Product Code: OAE
• UDI-Device Identifier: 08714729937449
• UDI-Public: 08714729937449
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P150005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2018

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: 11/01/2020
• Device Model Number: M004R9620K20
• Device Catalogue Number: R9620K2
• Device Lot Number: 21332456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 68