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

Model Number	81735
Medical Device Problem Codes	Fracture (1260); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that guide wire fracture occurred.The target lesion was located in a hepatic vessel.A 165 cm transcend guide wire was used; however, the device failed to pass through the catheter and fractured.The device was completely removed from the catheter and the procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.The device returned with a torque device attached to the guidewire.The guidewire was inspected and only a kink in the distal tip was found.The outer diameter of the distal tip, middle and proximal sections of the device are within specifications.
Event or Problem Description
It was reported that guide wire fracture occurred.The target lesion was located in a hepatic vessel.A165cm transend guide wire was used; however, the device failed to pass through the catheter and fractured.The device was completely removed from the catheter and the procedure was completed with another of the same device.No patient complications were reported and patient's status was stable.

• Brand Name: TRANSEND
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8812768
• Report Number: 2134265-2019-08431
• Device Sequence Number: 14057752
• Product Code: DQX
• UDI-Device Identifier: 08714729326281
• UDI-Public: 08714729326281
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K941710
• 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): 09/05/2019

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: 01/20/2021
• Device Model Number: 81735
• Device Catalogue Number: 81735
• Device Lot Number: 0023222495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 09/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1