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 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.(b)(4).The device was returned for analysis.Microscopic inspection of the control unit, motor housing and working length and tip/tip housing were performed and served no visible damage or irregularities.Functional testing was performed by turning on the device and the device turned on and all the led lights lite up as they were supposed to and the normal audible noise was heard.However, the red light flashed off and on and the device kept beeping during the audible noise.The device vibrated/rotated but the tip did not rotate.The screws were removed from the motor housing and the drive shaft was still attached.The blue detachment (shroud) was taken off, to remove the motor from the housing.The drive shaft became detached during analysis when the blue shroud was turned.There was no damage to the motor, the drive shaft was found to be kinked proximal to where the drive shaft was detached.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

Reportable based on device analysis completed on (b)(6) 2018.It was reported that the alert mode keeps on flashing.During preparation, a truepath was used and the power was turned on, however the alert mode was flashing.The device was reconnected and turned on but the alert mode was still flashing and did not work normally.The procedure was completed with another of the same device.No patient complications were reported and there were no patient injury.However, device analysis revealed that the outer shaft vibrated/rotated.

• 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: 7330666
• MDR Text Key: 102108749
• Report Number: 2134265-2018-01693
• 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: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/16/2019
• Device Model Number: H74939208181650
• Device Catalogue Number: 39208-18165
• Device Lot Number: 21156708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2017
• 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
• Treatment: INTRODUCER SHEATH- 6F TERUMO