MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CORK TRUEPATH¿; WIRE, GUIDE, CATHETER

Model Number H74939208181650

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 12/26/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older (b)(4).Device evaluated by manufacturer: the device was returned for analysis.Microscopic examination of the control unit, motor housing and working length and tip/tip housing were performed and revealed that the tip was shaped.There was no damage or irregularities identified during analysis.Functional testing of the device observed that when the device was turned on the outer shaft rotates with the tip.When the device was taken apart and the collet was loosened and removed, no damage or abnormalities were present.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

Reportable based on device analysis completed on 26-jan-2018.It was reported that the alert mode lit up and produced a sound.The chronic totally occluded (cto) target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery.A truepath¿ was selected for use.During preparation, the control unit and motor housing was connected and the power was turned on.However, a malfunction occurred as the alert mode lit up and produced a sound from the beginning instead of being in active mode.The issue was not resolved even after pressing the reset.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that the outer shaft rotates with the tip.

• Brand Name: TRUEPATH¿
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer (Section G): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7285555
• MDR Text Key: 100781122
• Report Number: 2134265-2018-00985
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K101599
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2019
• Device Model Number: H74939208181650
• Device Catalogue Number: 39208-18165
• Device Lot Number: 0021260250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2017
• 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