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

Model Number	1006
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the wire broke inside the patient.A savion flx guidewire was selected for a lower extremity intervention.As the physician was trying to cross the lesion, the wire broke.The entire wire was then retrieved from the patient.The patient experienced no complications and was fine post-procedure.
Event or Problem Description
It was reported that the wire broke inside the patient.A savion flx guidewire was selected for a lower extremity intervention.As the physician was trying to cross the lesion, the wire broke.The entire wire was then retrieved from the patient.The patient experienced no complications and was fine post-procedure.
Additional Manufacturer Narrative
Device eval by manufacturer: the device was broken 262 cm proximal to fractured section and 38 cm distal to proximal section.The device was kinked at the distal tip.Overall length could not be measured due to condition of device.The outer diameter of the distal tip, middle, and proximal sections were within specifications.

• Brand Name: SAVION FLX
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8527898
• Report Number: 2134265-2019-04001
• Device Sequence Number: 11233718
• Product Code: DQX
• UDI-Device Identifier: 08714729978824
• UDI-Public: 08714729978824
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K180726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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: 01/15/2021
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0023200713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: 03/26/2019
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1