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	01/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the tip detached.A savion flx wire was selected for a procedure in the totally occluded lesion in the severely calcified posterior tibial artery.The physician highly manipulated the savion flx wire in an attempt to enter the lesion.The savion flx wire was unable to enter the lesion due to the severe calcification.The savion flx wire was removed to attempt a new wire.Upon removing the savion flx wire, it was observed that the tip of the wire was detached and remaining inside the patient.As the vessel was already occluded, the tip fragment was not causing any patient complications.The procedure was completed with a new savion flx wire.The patient was ok post procedure.
Event or Problem Description
It was reported the tip detached.A savion flx wire was selected for a procedure in the totally occluded lesion in the severely calcified posterior tibial artery.The physician highly manipulated the savion flx wire in an attempt to enter the lesion.The savion flx wire was unable to enter the lesion due to the severe calcification.The savion flx wire was removed to attempt a new wire.Upon removing the savion flx wire, it was observed that the tip of the wire was detached and remaining inside the patient.As the vessel was already occluded, the tip fragment was not causing any patient complications.The procedure was completed with a new savion flx wire.The patient was ok post procedure.It was further reported that: the procedure team tried to catch the tip fragment with a lasso but it did not work because it was such a small fragment.The patient has since been discharged home.
Additional Manufacturer Narrative
B5: describe event or problem: updated.H6: impact codes: added prolonged surgery for the lasso needed.
Event or Problem Description
It was reported the tip detached.A savion flx wire was selected for a procedure in the totally occluded lesion in the severely calcified posterior tibial artery.The physician highly manipulated the savion flx wire in an attempt to enter the lesion.The savion flx wire was unable to enter the lesion due to the severe calcification.The savion flx wire was removed to attempt a new wire.Upon removing the savion flx wire, it was observed that the tip of the wire was detached and remaining inside the patient.As the vessel was already occluded, the tip fragment was not causing any patient complications.The procedure was completed with a new savion flx wire.The patient was ok post procedure.It was further reported that: the procedure team tried to catch the tip fragment with a lasso but it did not work because it was such a small fragment.The patient has since been discharged home.
Additional Manufacturer Narrative
B5: describe event or problem: updated.H6: impact codes: added prolonged surgery for the lasso needed.Device eval by manufacturer: the guidewire was returned for analysis.The small portion of the polymer jacket was detached at the very tip and not returned.Dimensional inspection was performed, and the outer diameters at the proximal, mid, and distal sections were found to be within specification.The overall length could not be measured due to the detached polymer section.

• 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: 11227385
• Report Number: 2134265-2021-00745
• Device Sequence Number: 3616574
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2021

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: 02/08/2021
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 01/26/2021; 02/16/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 02/10/2021; 03/08/2021
• 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