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

Model Number	39539
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that tip detachment occurred.The 100% stenosed moderately tortuous and severely calcified lesion was located in superficial femoral artery.A truepath was selected for use and during removal a thread-like fragment was observed and the tip was stretched and detached.The procedure was completed using a different device and no patient complications were reported.

• 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: 8021141
• Report Number: 2134265-2018-62481
• Device Sequence Number: 16426939
• 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): 10/30/2018

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: 01/23/2020
• Device Model Number: 39539
• Device Catalogue Number: 39539
• Device Lot Number: 0021795243
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2018
• Initial Report FDA Received Date: 10/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 53