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 Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/18/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the guidewire tip detached inside the patient.A savion flx guidewire was selected for use in a procedure with retrograde access and a 5f sheath.During the procedure, the tip of the guidewire detached in the distal anterior tibial artery.There was no way to retrieve the guidewire fragment.Flow to the patient's artery was not affected.
Event or Problem Description
It was reported that the guidewire tip detached inside the patient.A savion flx guidewire was selected for use in a procedure with retrograde access and a 5f sheath.During the procedure, the tip of the guidewire detached in the distal anterior tibial artery.There was no way to retrieve the guidewire fragment.Flow to the patient's artery was not affected.It was further reported that the lesion was extremely calcified and stenosis was 90%.Attempts were made to retrieve the detached wire by aspiration and using a snare catheter, but it was irretrievable.The procedure was rescheduled and a stent was used to affix and appose the detached tip against the vessel wall.

• 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: 10488554
• Report Number: 2134265-2020-12241
• Device Sequence Number: 14114145
• Product Code: DQX
• UDI-Device Identifier: 08714729978831
• UDI-Public: 08714729978831
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/23/2020

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: 07/04/2021
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0024063512
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/18/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 09/23/2020
• 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; Required Intervention
• Patient Age: 67 YR