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	09/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.The occluded target lesion was located in the mildly tortuous proximal anterior tibial artery.A savion flx guidewire was advanced for treatment.However, it was noted that the tip of wire came off inside the patient body.The lesion was already occluded so the physician decided just to leave it and treat the peroneal artery.The procedure was completed with a non boston scientific device.There were no patient complications reported.The patient was fine and fully recovered.
Additional Manufacturer Narrative
Device evaluated by mfr: unit returned in a generic plastic bag.The unit returned has the tip damaged, as part of overall visual revision.The returned device matches with upn and lot provided by the customer.The returned guidewire had the distal tip portion with polymer detached.The end distal tip was found bent.No other issues were found.The device was measured in three sections (distal - medium - proximal) which confirmed that was within specification.
Event or Problem Description
It was reported that tip detachment occurred.The occluded target lesion was located in the mildly tortuous proximal anterior tibial artery.A savion flx guidewire was advanced for treatment.However, it was noted that the tip of wire came off inside the patient body.The lesion was already occluded so the physician decided just to leave it and treat the peroneal artery.The procedure was completed with a non boston scientific device.There were no patient complications reported.The patient was fine and fully recovered.

• 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: 12553836
• Report Number: 2134265-2021-11752
• Device Sequence Number: 19078399
• 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): 10/25/2021

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: 06/25/2023
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0027564155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 10/05/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 10/25/2021
• 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: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 77