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	Foreign Body In Patient (2687)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the detached guidewire tip could not be retrieved.A savion flx was selected for use.The guidewire was advanced into the lower leg and into stenosed and calcified anterior tibial artery.The channel was narrow but the guidewire was placed.However, the physician observed that the distal tip had detached.A snare was unsuccessful in removing the tip.There were no patient complications and no further intervention is planned.
Additional Manufacturer Narrative
Device eval by mfr: the guidewire was returned and it was observed that the distal tip was detached.Under microscope it was observed that the distal tip of the guidewire was detached.Inspection of the remainder of the device revealed no other damage or irregularities.
Event or Problem Description
It was reported that the detached guidewire tip could not be retrieved.A savion flx was selected for use.The guidewire was advanced into the lower leg and into stenosed and calcified anterior tibial artery.The channel was narrow but the guidewire was placed.However, the physician observed that the distal tip had detached.A snare was unsuccessful in removing the tip.There were no patient complications and no further intervention is planned.

• Brand Name: SAVION FLX
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 14681763
• Report Number: 2134265-2022-06451
• Device Sequence Number: 4791621
• Product Code: DQX
• UDI-Device Identifier: 08714729978817
• UDI-Public: 08714729978817
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2023

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: 08/11/2023
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0027820553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 06/13/2022
• Supplement Report FDA Received Date: 01/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown