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

Model Number	1006
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the guidewire tip detached.A savion flx guidewire was selected for use in the 50% stenosed right anterior tibial artery (ata).While trying to navigate the calcified ata, the guidewire tip detached.Ivus showed that the fragment was not in the vessel lumen.The physician thought the detached tip occurred because the wire was in a dissection plane of the calcified artery.It was decided that it posed no risk of being in the false lumen so it was not retrieved.A different guidewire was used to complete the procedure.There was online blood flow to the foot and three vessel tibial runoff.The patient condition post-procedure was good.
Additional Manufacturer Narrative
Device analysis by mfr: the returned guidewire had the distal tip bent and the polymer distal tip was detached.The detached section was not returned.The damaged section was located approximately at 298.4 cm from the proximal end.No other visual damage was found in the device.Dimensional inspection of the overall length and distal tip could not be performed due to the detached polymer tip.Dimensional inspection of the middle and proximal section of the device found it was within specification.
Event or Problem Description
It was reported that the guidewire tip detached.A savion flx guidewire was selected for use in the 50% stenosed right anterior tibial artery (ata).While trying to navigate the calcified ata, the guidewire tip detached.Ivus showed that the fragment was not in the vessel lumen.The physician thought the detached tip occurred because the wire was in a dissection plane of the calcified artery.It was decided that it posed no risk of being in the false lumen so it was not retrieved.A different guidewire was used to complete the procedure.There was online blood flow to the foot and three vessel tibial runoff.The patient condition post-procedure was good.It was further reported that the dissection was intentionally created with the wire and balloon system.

• 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: 9985976
• Report Number: 2134265-2020-05432
• Device Sequence Number: 17117579
• 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,Followup
• Report Date (Section B): 05/14/2020

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: 02/04/2022
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0025161705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 04/22/2020
• Supplement Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR