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	11/06/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the distal tip of the guidewire detached.A savion flx guidewire was selected for use for a superficial femoral artery (sfa) intervention procedure.During the procedure, the distal tip of the guidewire became detached and it was unable to be retrieved.The detached tip of the guidewire was not recovered and was left in the patient.The sfa treatment was completed.No further complications were reported.Another attempt the retrieve the wire was to be attempted the following week.
Event or Problem Description
It was reported that the distal tip of the guidewire detached.A savion flx guidewire was selected for use for a superficial femoral artery (sfa) intervention procedure.During the procedure, the distal tip of the guidewire became detached and it was unable to be retrieved.The detached tip of the guidewire was not recovered and was left in the patient.The sfa treatment was completed.No further complications were reported.Another attempt the retrieve the wire was to be attempted the following week.It was further reported that the tip of the guidewire became separated in a part of the vessel that did not have disease where there was no calcification and very mild tortuosity.Patient has not yet undergone surgery to remove the remaining fragment of guidewire and it is unknown whether further removal attempts will occur.The patient was in stable condition.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the returned product consisted of a savion flx guidewire.Visual inspection of the device revealed that the distal tip broken/fractured and kinked.The damaged section was located approximately at 261.4 cm from the proximal end.Dimensional measurement found that the overall dimension of middle of the device and proximal section were within specification.An overall length and overall dimension of distal tip could not be performed due to the guidewire broken/fractured at the distal end.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
It was reported that the distal tip of the guidewire detached.A savion flx guidewire was selected for use for a superficial femoral artery (sfa) intervention procedure.During the procedure, the distal tip of the guidewire became detached and it was unable to be retrieved.The detached tip of the guidewire was not recovered and was left in the patient.The sfa treatment was completed.No further complications were reported.Another attempt the retrieve the wire was to be attempted the following week.It was further reported that the tip of the guidewire became separated in a part of the vessel that did not have disease where there was no calcification and very mild tortuosity.Patient has not yet undergone surgery to remove the remaining fragment of guidewire and it is unknown whether further removal attempts will occur.The patient was in stable condition.

• 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: 9369146
• Report Number: 2134265-2019-14393
• Device Sequence Number: 19593900
• Product Code: DQX
• UDI-Device Identifier: 08714729978817
• UDI-Public: 08714729978817
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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,Followup
• Report Date (Section B): 02/18/2020

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 Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0023944219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 11/25/2019; 01/30/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/02/2019; 02/18/2020
• 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