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	02/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that the tip looked separated the chronic total occlude target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery.A truepath device was selected for use.During procedure, the device was pushed and pulled in accordance with the lamp.Consequently, it seemed like the gold tip housing of the device was separated under fluoroscopy.However, the radiopaque tip of the device cannot be seen on the screen because it was transparent.The device was then simply pulled out from the patient's body and there were no fragments of the device left inside.No complications reported and there were no injury to the patient.
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 a truepath device.The control unit, motor housing, working length, tip housing/tip were visually examined.There was damage to the proximal end of the coil of the tip.The tip was stretched and the distal end of the coil of the tip was separated from the hypotube/tip housing and uncoiled; however, the tip was attached and jammed into the tip housing.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis confirmed the reported event, as the distal end of coil of the tip was separated from the housing.The location of the separation and the confirmed damage, indicates that the detached coil was due to the usage of the device and advancing the device in the 100% stenosed lesion.
Event or Problem Description
It was reported that the tip looked separated.The chronic total occluded target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery.A truepath device was selected for use.During procedure, the device was pushed and pulled in accordance with the control unit.Consequently, it seemed like the gold tip housing of the device was separated under fluoroscopy.However, the radiopaque tip of the device cannot be seen on the screen because it was transparent.The device was then simply pulled out from the patient's body and there were no fragments of the device left inside.No complications reported and there were no injury to the patient.

• 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: 8433550
• Report Number: 2134265-2019-02663
• Device Sequence Number: 11411540
• 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): 04/12/2019

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: 04/08/2020
• Device Model Number: 39539
• Device Catalogue Number: 39539
• Device Lot Number: 0022112543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: 02/24/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 04/12/2019
• 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: GUIDE CATHETER: PROMINENT RAPTOR; GUIDE CATHETER: PROMINENT RAPTOR; GUIDE CATHETER: PROMINENT RAPTOR