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	02/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the mildly tortuous and severely calcified pedal artery (pa).A savion flx guidewire was advanced to gain access from the foot up to the peroneal artery.However, during the procedure, a bit of resistance was felt upon attempting to advance the device and the entire floppy tip of the guidewire broke off in pa and was left behind.The wire was removed but the tip of the guidewire had to be left in the patient's foot due to the size of the vessel and no device or snare small enough to attempt a retrieval.The procedure was completed with another savion guidewire.No patient complications were reported.
Event or Problem Description
It was reported that tip detachment occurred.The target lesion was located in the mildly tortuous and severely calcified pedal artery (pa).A savion flx guidewire was advanced to gain access from the foot up to the peroneal artery.However, during the procedure, a bit of resistance was felt upon attempting to advance the device and the entire floppy tip of the guidewire broke off in pa and was left behind.The wire was removed but the tip of the guidewire had to be left in the patient's foot due to the size of the vessel and no device or snare small enough to attempt a retrieval.The procedure was completed with another savion guidewire.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: unit returned, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The device was inspected according to procedure: the returned guidewire had the distal tip portion with polymer section detached.No other issues were found.The device was measured in three sections (distal - medium - proximal).The distal, medium and proximal outer diameter were within specifications.

• 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: 13586585
• Report Number: 2134265-2022-01373
• Device Sequence Number: 12173268
• Product Code: DQX
• UDI-Device Identifier: 08714729978817
• UDI-Public: 08714729978817
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 03/23/2022

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: 09/03/2023
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0027964289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 03/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2021
• 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 Sex: Unknown