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	07/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the tip of the guidewire detached inside the patient, the device fragment was not retrieved, and the procedure was aborted.A savion flx guidewire was selected for an atherectomy and percutaneous transluminal angioplasty procedure to treat a chronic total occlusion of the left common plantar artery.The target lesion was severely calcified, and the anatomy was mildly tortuous.While backing the guidewire out of the lesion in an attempt to redirect the tip of the guidewire through the lesion again, the tip became stuck and eventually detached within the common plantar artery.The procedure was aborted.No attempts were made to retrieve the device fragment, and no additional interventions have been scheduled.No patient complications were reported, and the patient was in good condition with no change 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: 10426124
• Report Number: 2134265-2020-11323
• Device Sequence Number: 2881023
• Product Code: DQX
• UDI-Device Identifier: 08714729978817
• UDI-Public: 08714729978817
• 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
• Report Date (Section B): 08/19/2020

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: 06/15/2022
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0025600474
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 08/19/2020
• 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
• Patient Age: 67 YR