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	02/14/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip detached and remained in the patient.Vascular access to the lower leg was attempted via an antegrade approach from the groin.A.018" non-bsc guidewire was inserted to probe the lower right leg of the anterior tibialis posterior artery, but the vessel was closed.Several guidewires and a 0.18 rubicon support catheter were used to try to open the vessel without success.A savion flx guidewire and a rubicon catheter were advanced to the lesion in an attempt to open the vessel.11mm of the tip of the guidewire detached.The detached fragment remained in the vessel since the vessel was closed.The procedure was canceled and no further attempts were made.There were further patient complications.The patient's status was stable.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the guidewire was returned for analysis without the polymer distal tip.The distal tip was bent and the polymer distal tip was detached.The damaged section was located approximately at 298.7 cm from the proximal end.No more visual damages were found in the device.The outer diameter of the distal tip, middle section, and proximal section of the device were within specification.
Event or Problem Description
It was reported that the tip detached and remained in the patient.Vascular access to the lower leg was attempted via an antegrade approach from the groin.A.018" non-bsc guidewire was inserted to probe the lower right leg of the anterior tibialis posterior artery, but the vessel was closed.Several guidewires and a 0.18 rubicon support catheter were used to try to open the vessel without success.A savion flx guidewire and a rubicon catheter were advanced to the lesion in an attempt to open the vessel.11mm of the tip of the guidewire detached.The detached fragment remained in the vessel since the vessel was closed.The procedure was canceled and no further attempts were made.There were further patient complications.The patient's status was stable.It was further reported that the lesion was a long segment occlusion with no tortuosity and high grade calcification.The wire tip detached in the first segment when passing through the lesion with minimal force.The vessel was too small to retrieve the detached tip fragment.Re-occlusion of the vessel occurred after a few days.
Event or Problem Description
It was reported that the tip detached and remained in the patient.Vascular access to the lower leg was attempted via an antegrade approach from the groin.A.018" non-bsc guidewire was inserted to probe the lower right leg of the anterior tibialis posterior artery, but the vessel was closed.Several guidewires and a 0.18 rubicon support catheter were used to try to open the vessel without success.A savion flx guidewire and a rubicon catheter were advanced to the lesion in an attempt to open the vessel.11mm of the tip of the guidewire detached.The detached fragment remained in the vessel since the vessel was closed.The procedure was canceled and no further attempts were made.There were further patient complications.The patient's status was stable.It was further reported that the lesion was a long segment occlusion with no tortuosity and high grade calcification.The wire tip detached in the first segment when passing through the lesion with minimal force.The vessel was too small to retrieve the detached tip fragment.Re-occlusion of the vessel occurred after a few days.

• 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: 9758230
• Report Number: 2134265-2020-02084
• Device Sequence Number: 2787690
• Product Code: DQX
• UDI-Device Identifier: 08714729978824
• UDI-Public: 08714729978824
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 05/21/2020

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: 05/08/2021
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0023768335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Initial Date Received by Manufacturer: 02/14/2020
• Supplement Date Received by Manufacturer: 03/03/2020; 05/05/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 03/23/2020; 05/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 84 YR