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	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of the wire broke and was left in the patient.A savion flx guidewire was selected for use in a lower extremity intervention procedure.During the procedure, the tip of the wire broke off inside of the patient and the tip remains in the patient's body.No further patient complications occurred.
Event or Problem Description
It was reported that the tip of the wire broke and was left in the patient.A savion flx guidewire was selected for use in a lower extremity intervention procedure.During the procedure, the tip of the wire broke off inside of the patient and the tip remains in the patient's body.No further patient complications occurred.
Additional Manufacturer Narrative
Device evaluated by mfr: the guidewire was returned together with its original opened pouch and a torque device.The returned guidewire had the distal tip bent.No more visual damages were found in the device.During the microscopic inspection, it was found that the polymer jacket distal end had a detached section and it was not returned.The core wire protruded from the polymer jacket end.The dimensional inspection of the distal tip outer diameter (od), middle section od, and proximal section od were all within specifications.The overall length failed due to the detached polymer jacket.The detached section was located approximately at 117.5 inches from the proximal end.

• 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: 10307972
• Report Number: 2134265-2020-09683
• Device Sequence Number: 3417041
• Product Code: DQX
• UDI-Device Identifier: 08714729978817
• UDI-Public: 08714729978817
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: K180726
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2020

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: 04/02/2022
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0025439279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 09/14/2020
• 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: Other