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); Difficult to Advance (2920)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/03/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a tip break occurred and the tip remained in the patient.The target lesion was located in the severely calcified popliteal artery.A savion guidewire was selected for use.During advancement to the lesion, the guidewire had to be manipulated to pass the stenosis and the first 1cm of the tip broke.An attempt was made to snare the tip of the wire; however was unsuccessful and the tip of the guidewire remained in the patient.A different guidewire was used to complete the procedure.There were no patient complications reported and the patient's status is stable.
Event or Problem Description
It was reported that a tip break occurred and the tip remained in the patient.The target lesion was located in the severely calcified popliteal artery.A savion guidewire was selected for use.During advancement to the lesion, the guidewire had to be manipulated to pass the stenosis and the first 1cm of the tip broke.An attempt was made to snare the tip of the wire; however was unsuccessful and the tip of the guidewire remained in the patient.A different guidewire was used to complete the procedure.There were no patient complications reported and the patient's status is stable.
Additional Manufacturer Narrative
Device evaluation by manufacturer:the savion guidewire was returned for analysis.Visual and microscopic inspection revealed that the distal tip was bent and the body was bent 62 inches from the proximal end.The distal end polymer jacket had a detached section located 117.5 inches from the proximal end.The detached fragment was not returned.No further damage was found on the device.Dimensional inspection determined that the outer diameter of the middle and proximal sections of the device were within specification.Due to the detached polymer jacket, dimensional inspection of the overall length and distal tip outer diameter was unable to be completed.

• 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: 10253471
• Report Number: 2134265-2020-09083
• Device Sequence Number: 2577101
• Product Code: DQX
• UDI-Device Identifier: 08714729978824
• UDI-Public: 08714729978824
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K180726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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: 05/15/2021
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0023803642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Initial Date Received by Manufacturer: 07/03/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 07/09/2020
• Supplement Report FDA Received Date: 08/27/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention