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 Consequences Or Impact To Patient (2199)

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device evaluated by mfr: device was returned for analysis.Returned product consisted of a truepath device.The control unit, motor housing and working length and tip/tip housing were microscopically examined.There was saline on the shaft and tip of the device.The tip was shaped on the gold part which crimped the inner and outer together.The platinum coil is stretched at the proximal solder location.Functional testing performed and the device turned on and the outer shaft rotates with the inner due to the inner and outer being crimped together because the shaping was performed incorrectly.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 truepath dfu includes the following instruction for using the shaping tool: ¿if required, shape the truepath cto device tip using the shaping tool.Align the shaping tool knob to its starting orientation.Insert the distal end of the cto device along the groove in the shaping tool base until the tip abuts the end of the shaping tool (as visualized in the window in the base of the shaping tool).Rotate the knob clockwise until locked (audible click).Gently remove the shaped cto device from the shaping tool.¿ (b)(4).

Event Description

Reportable based on device analysis completed on 26-jan-2018.It was reported that the tip failed/unable to rotate.A truepath¿ cto device was selected for use.During procedure, it was noted that, though motor was running, the tip of the truepath quits spinning after 15-20 seconds.Procedure was completed with another of the same device.No patient complications were reported and the patient's status was good.However, device analysis revealed that the outer shaft rotates with the inner.

• 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: 7286081
• MDR Text Key: 100776700
• Report Number: 2134265-2018-00982
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101599
• 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
• Report Date: 01/26/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2019
• Device Model Number: H74939208181650
• Device Catalogue Number: 39208-18165
• Device Lot Number: 0020836114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2018
• Initial Date FDA Received: 02/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2017
• 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