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

Model Number	1006
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device eval by manufacturer:the guidewire returned for analysis.The guidewire had the distal tip kinked/bent.The polymer jacket distal end was detached and it was not returned.The detached section was located approximately at 298.4 cm from the proximal end.The kinked/bent section found in the distal tip was located approximately at 297 cm from the proximal end.No more visual damages were found in the device.The outer diameter of the middle and proximal section of the device were within specification.
Event or Problem Description
It was reported that the guidewire tip detached inside the patient.A savion flx guidewire was selected for a procedure.While crossing the pedal plantar loop, there was no heavy calcium, but the guidewire bent back on itself, and the distal tip of the guidewire detached in the distal anterior tibial artery.The physician was able to retrieve the guidewire fragment with a non-bsc snare.The procedure was completed, and there were no patient complications reported.

• 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: 10143770
• Report Number: 2134265-2020-07795
• Device Sequence Number: 3053349
• Product Code: DQX
• UDI-Device Identifier: 08714729978824
• UDI-Public: 08714729978824
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/17/2022
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0025368625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 06/11/2020
• 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: MERIT MEDICAL EN SNARE
• Outcome Attributed to Adverse Event: Required Intervention