MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SAVION FLX; WIRE, GUIDE, CATHETER

Model Number	1006
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	06/22/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment remained in the patient and thrombosis occurred.The totally occluded target lesion was located in mildly tortuous and moderately calcified posterior tibial artery (pta).A savion flx guidewire was advanced for crossing the lesion.However, when trying to advance down the pta, the distal tip of the wire was broken to 1-2cm.Subsequently, thrombus was formed around the wire.No attempt was made to snare the wire as the area was occluded.An antiplatelet medication-heparin was given to the patient prior to and during the procedure.The procedure was completed with a non-boston scientific guide wire.No further patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the unit returned with its original pouch.Overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The device distal section was found bent.No other issues were found.Photos were taken and it was possible to observed a section detached and kinked at very tip and distal end bent.The outer diameter of the distal, medium, and proximal sections of the device are within specifications.The overall length inspection could not be performed due to device condition (polymer detached section).
Event or Problem Description
It was reported that tip detachment remained in the patient and thrombosis occurred.The totally occluded target lesion was located in mildly tortuous and moderately calcified posterior tibial artery (pta).A savion flx guidewire was advanced for crossing the lesion.However, when trying to advance down the pta, the distal tip of the wire was broken to 1-2cm.Subsequently, thrombus was formed around the wire.No attempt was made to snare the wire as the area was occluded.An antiplatelet medication-heparin was given to the patient prior to and during the procedure.The procedure was completed with a non-boston scientific guide wire.No further 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
• MDR Report Key: 12170199
• Report Number: 2134265-2021-09014
• Device Sequence Number: 4581167
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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: 07/06/2021
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 07/14/2021
• Supplement Report FDA Received Date: 07/30/2021
• 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
• Patient Age: 68 YR