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

Model Number	1006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the guidewire became loose.A savion flx guidewire was selected for revascularization procedure in the popliteal artery.During the procedure inside the patient's body, the nitinol part of the tip became loose and was barely hanging on to the rest of the guidewire.The device was removed and the procedure was completed with a different device.There were no patient complications reported and the patient was fine post procedure.
Event or Problem Description
It was reported that the tip of the guidewire became loose.A savion flx guidewire was selected for revascularization procedure in the popliteal artery.During the procedure inside the patient's body, the nitinol part of the tip became loose and was barely hanging on to the rest of the guidewire.The device was removed and the procedure was completed with a different device.There were no patient complications reported and the patient was fine post procedure.
Additional Manufacturer Narrative
Evaluation conclusion codes: corrected from 67 to 4311.

• 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: 8813180
• Report Number: 2134265-2019-08095
• Device Sequence Number: 2399633
• Product Code: DQX
• UDI-Device Identifier: 08714729978817
• UDI-Public: 08714729978817
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2020
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0022941084
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1