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

Model Number	39539
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event- 18 years or older.Device evaluated by manufacturer: the device was returned for analysis.Returned product consisted of portion of the truepath device.The hypotube, tip and portion of the drive shaft were not returned for analysis.The control unit, motor housing, working length, tip housing/tip were visually examined.The drive shaft was detached 91cm distal of the collet strain relief.The end of the detachment was jagged, indicating force was applied to the drive shaft.The blue shroud was pulled distally 1cm with the shroud detachment pin was missing.The motor housing was taken apart and the collet was loosened and removed, the drive shaft was still attached to the motor coupling and there were no damage or irregularities to the components inside the motor housing.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 11-jan-2019.It was reported that the device no longer functioned.The 100% stenosed target lesion was located in the superficial femoral artery.A truepath was selected for use.During procedure, it was noted that the device no longer functioned as it stopped activating.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that the drive shaft was detached.

• 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: 8297698
• Report Number: 2134265-2019-00682
• Device Sequence Number: 14128632
• 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): 02/01/2019

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: 01/23/2020
• Device Model Number: 39539
• Device Catalogue Number: 39539
• Device Lot Number: 0021795243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/01/2019
• Patient Sequence Number: 1