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 Code Available (3191)
Date of Event	12/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient was born in (b)(6).
Event or Problem Description
It was reported that the tip of the guidewire broke off during a procedure.A savion flx guidewire was selected for a procedure and during the attempt to cross the right leg lateral plantar in the foot, approximately 5mm of the distal tip of the wire broke off in the patient's artery.The physician used a coronary snare to remove the wire fragment.The procedure was completed using a non-bsc wire.There were no patient complications reported.
Additional Manufacturer Narrative
A2: patient was born in 1941.Device analysis by mfr: the guidewire was returned with distal tip damage.The device was broken 299.2 cm from the proximal end.The device was kinked at the distal tip.No more damages were found in the device.Dimensional inspection found the distal tip, middle of the device, and proximal section were within specifications.
Event or Problem Description
It was reported that the tip of the guidewire broke off during a procedure.A savion flx guidewire was selected for a procedure and during the attempt to cross the right leg lateral plantar in the foot, approximately 5mm of the distal tip of the wire broke off in the patient's artery.The physician used a coronary snare to remove the wire fragment.The procedure was completed using a non-bsc wire.There were no patient complications reported.

• 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: 9488631
• Report Number: 2134265-2019-15890
• Device Sequence Number: 296791
• Product Code: DQX
• UDI-Device Identifier: 08714729978824
• UDI-Public: 08714729978824
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/20/2020

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: 09/16/2021
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0024445679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 02/20/2020
• 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