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

Model Number	39539
Medical Device Problem Codes	Failure to Advance (2524); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the shaft could not be seen on x-ray vascular access was obtained utilizing cross over approach.The chronic totally occluded (cto) target lesion was located in the moderately tortuous and mildly calcified superficial femoral artery (sfa).A truepath was selected for use.During procedure, the device was used in combination with support by cross over approach at the cto lesion in sfa of about 15cm and the radiopaque marker area was partially penetrated/went through.However, the shaft could not be seen because of the viewing angle of x-ray; made it difficult to see.The device was then removed and the procedure was completed with another truepath.No patient complications were reported and the patient's status was good.

• Brand Name: TRUEPATH
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road,; cork ; EI
• MDR Report Key: 7836890
• Report Number: 2134265-2018-60648
• Device Sequence Number: 16423204
• 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): 08/31/2018

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: 12/05/2019
• Device Model Number: 39539
• Device Catalogue Number: 39539
• Device Lot Number: 0021586516
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 08/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1