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

Model Number	H74939208181650
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2018
Type of Reportable Event	Malfunction
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 and working length and tip/tip housing were microscopically examined.There was foreign matter, fibers, wrapped around the tip.There is saline along the shaft and the tip.The device was soaked and the foreign matter was removed.There was no other visible damage or irregularities.Functional testing was performed on the device.When the device was turned on the alert mode was on and the outer shaft rotates with the tip.The device was taken apart and the collet was loosened and removed, no damage or abnormalities were present.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion was unable to be determined.(b)(4).
Event or Problem Description
Reportable based on device analysis completed on 23-feb-2018.It was reported that the tip failed to rotate.The chronic totally occluded target lesion was located in the moderately tortuous and severely calcified superficial femoral artery.A truepath¿ cto device was selected for use.During the procedure, when the device was inserted inside the patient's body, it was noted that the tip of the truepath¿ device stopped rotating.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that there were fibers wrapped around the tip and the outer shaft rotates with the tip.

• Brand Name: TRUEPATH¿
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC - CORK; business and technology park; model farm road; cork ; EI
• MDR Report Key: 7343005
• Report Number: 2134265-2018-02028
• Device Sequence Number: 18868987
• Product Code: DQX
• UDI-Device Identifier: 08714729820284
• UDI-Public: 08714729820284
• Combination Product (Y/N): N
• PMA/510(K) Number: K101599
• 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): 02/23/2018

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: 11/03/2019
• Device Model Number: H74939208181650
• Device Catalogue Number: 39208-18165
• Device Lot Number: 0021486374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1