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	06/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that guidewire detachment occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified distal posterior tibial artery (pta).A savion flx guidewire was advanced to cross the lesion.However, during the procedure, the guidewire fractured off 2-3 cm distal of the wire.The detached fragment was lodged in the distal part of the pta.The detached portion was in too small of a vessel and could not be retrieved.The procedure was completed with another savion wire.
Event or Problem Description
It was reported that guidewire detachment occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified distal posterior tibial artery (pta).A savion flx guidewire was advanced to cross the lesion.However, during the procedure, the guidewire fractured off 2-3 cm distal of the wire.The detached fragment was lodged in the distal part of the pta.The detached portion was in too small of a vessel and could not be retrieved.The procedure was completed with another savion wire.
Additional Manufacturer Narrative
Device evaluated by mfr: unit returned in a generic plastic bag, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned device matches with upn and lot provided by the customer.The returned guidewire had the distal tip portion with polymer detached.No other issues were found.Photos were taken of polymer detached at very tip.The device was measured in three sections (distal - medium - proximal) and was confirmed to be within specification.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12178861
• Report Number: 2134265-2021-08953
• Device Sequence Number: 898138
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2021

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: 01/13/2023
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0026631717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/24/2021
• Supplement Date Received by Manufacturer: 11/25/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2021
• 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: Other
• Patient Age: 59 YR
• Patient Sex: Male