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 Consequences Or Impact To Patient (2199)
Date of Event	11/30/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the guidewire tip detached inside the patient.A savion flx guidewire was selected for a percutaneous transluminal angioplasty procedure below the knee.As the guidewire was advanced into the patient, it was difficult to explore the vessel below the knee and into the anterior tibial artery because the guidewire went subintimal.During the procedure the guidewire tip detached inside the patient 2cm from the tip.The detachment occurred below the knee in the anterior tibial artery.The detached tip was removed with a snare.A new device, same model, was selected to complete the procedure.There were no patient complications.The patient condition following the procedure was reported as stable.
Additional Manufacturer Narrative
Device analysis by mfr: inspection of the device found the distal tip was fractured.The detached section was returned.The damaged section was located approximately at 298.5 cm from the proximal end.The distal tip was kinked.No further damage was found in the device.The outer diameter of the middle, proximal, and distal tip were within specification.
Event or Problem Description
It was reported that the guidewire tip detached inside the patient.A savion flx guidewire was selected for a percutaneous transluminal angioplasty procedure below the knee.As the guidewire was advanced into the patient, it was difficult to explore the vessel below the knee and into the anterior tibial artery because the guidewire went subintimal.During the procedure the guidewire tip detached inside the patient 2cm from the tip.The detachment occurred below the knee in the anterior tibial artery.The detached tip was removed with a snare.A new device, same model, was selected to complete the procedure.There were no patient complications.The patient condition following the procedure was reported as stable.

• 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: 9453193
• Report Number: 2134265-2019-15398
• Device Sequence Number: 19361491
• Product Code: DQX
• UDI-Device Identifier: 08714729978824
• UDI-Public: 08714729978824
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K180726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2020

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: 04/24/2021
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0023696454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 12/04/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 02/03/2020
• 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