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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that coating issue occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery.A savion flx guidewire was advanced for use.However, when placing the catheter over the wire, the wire coating was peeled.The device was removed intact and another savion guidewire was used to complete the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the guidewire was returned, and no damages were observed.No issues were observed at the coating of the device.The device was soaked in saline solution in order to activate the coating at distal section.When the coating was activated, no issues were identified in the distal tip coating.
Event or Problem Description
It was reported that coating issue occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified superficial femoral artery.A savion flx guidewire was advanced for use.However, when placing the catheter over the wire, the wire coating was peeled.The device was removed intact and another savion guidewire was used to complete the procedure.No patient complications were reported.

• 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: 15584825
• Report Number: 2124215-2022-38226
• Device Sequence Number: 11444274
• Product Code: DQX
• UDI-Device Identifier: 08714729978817
• UDI-Public: 08714729978817
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/19/2024
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0029255521
• 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: 09/20/2022
• Supplement Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2022
• 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
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Race: Black Or African American