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

Model Number	39539
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device broke.The chronic total occlusion target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A truepath was selected for use.During procedure, it was noted under fluoroscopy that part of the radiopaque marker of the tip was thin at about 5mm while manipulating.It was then judged to be broken and was simply pulled out from the patient's body.The device was visually inspected outside the patient's body and there were no abnormalities observed.The procedure was completed wit another of the same device.No patient complications were reported and the patient was stable.
Additional Manufacturer Narrative
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.Saline were present on the shaft and tip of the device.Majority of the proximal end of the coil at the tip was stretched and coil at the distal end of the tip was unraveled.A photo was returned and attached to the complaint record.The photo was reviewed by the personnel from the mg cis (maple grove complaint investigation site) and it was found that the light area is where the confirmed unraveled coil was located on the device.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that the device broke.The chronic total occlusion target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A truepath was selected for use.During procedure, it was noted under fluoroscopy that part of the radiopaque marker of the tip was thin at about 5mm while manipulating.It was then judged to be broken and was simply pulled out from the patient's body.The device was visually inspected outside the patient's body and there were no abnormalities observed.The procedure was completed wit another of the same device.No patient complications were reported and the patient was stable.

• 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: 8142085
• Report Number: 2134265-2018-63661
• Device Sequence Number: 13889646
• 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,Followup
• Report Date (Section B): 01/03/2019

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: 02/13/2020
• Device Model Number: 39539
• Device Catalogue Number: 39539
• Device Lot Number: 0021882408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 12/07/2018
• Supplement Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTRODUCER SHEATH: DESTINATION 6F