MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRUEPATH; WIRE, GUIDE, CATHETER

Model Number	39539
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
Reportable based on device analysis completed on 17-nov-2018 it was reported that the three lamps lit on.The 99% stenosed target lesion was located in the mildly tortuous and mildly calcified left femoral artery.A truepath was selected for use.During the procedure, the device was delivered after tip shaping; however, three lamps immediately lit on.The device was reconnected and the tip part was washed with saline, but the issue was not resolved.The tip of the device was not rotating but the entire distal section near the tip looked like rotating, weltering, and twisting.There were sound of resistance while rotating and the noise was different than usual.The procedure was completed with another of same device.No patient complications were reported.However, device analysis revealed that the drive shaft was separated from the motor.Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of a truepath device.The control unit, motor housing, working length, tip housing/tip were microscopically examined.The coils at the proximal portion on of the tip was stretched.Functional testing was performed by turning on the device.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 greens light lite but the red light also lite up and the tip did not rotate.The device was taken apart and the collet was loosened and removed, it was found that the drive shaft is separated from the motor at the location of where the blue shroud would separate the shaft if the shroud was turned.Inspection of the remainder of the device presented no other damage or irregularities.

• Brand Name: TRUEPATH
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8151186
• Report Number: 2134265-2018-63803
• Device Sequence Number: 1770698
• Product Code: PDU
• UDI-Device Identifier: 08714729820284
• UDI-Public: 08714729820284
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140288
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

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: 12/14/2019
• Device Model Number: 39539
• Device Catalogue Number: 39539
• Device Lot Number: 0021626014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2018
• Initial Report FDA Received Date: 12/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1