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 Codes	No Consequences Or Impact To Patient (2199); Device Embedded In Tissue or Plaque (3165)
Date of Event	07/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a tip detachment occurred.A savion flx guidewire was selected for a procedure.The lesion presented severe calcification.During the procedure, there was wear on the guide from the calcification and the distal tip of the guidewire detached.The device was removed and the event was resolved.The procedure was completed with a different device.There were no patient complications reported.
Event or Problem Description
It was reported that a tip detachment occurred.A savion flx guidewire was selected for a procedure.The lesion presented severe calcification.During the procedure, there was wear on the guide from the calcification and the distal tip of the guidewire detached.The device was removed and the event was resolved.The procedure was completed with a different device.There were no patient complications reported.Additional information reported that the procedure was for a total occlusion using an endoluminal approach.The tip of the guidewire was left inside the patient.No maneuvers were attempted to remove the guidewire tip.A non-bsc device was used to treat the occlusion.The patient had no complications and was stable post procedure.

• 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: 8875345
• Report Number: 2134265-2019-09320
• Device Sequence Number: 2624816
• Product Code: DQX
• UDI-Device Identifier: 08714729978817
• UDI-Public: 08714729978817
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 09/09/2019

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: 04/22/2021
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0023684765
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: COOK CXI 0.018 GUIDE CATHETER
• Outcome Attributed to Adverse Event: Other