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	08/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: over (b)(6) years old.
Event or Problem Description
It was reported that the tip detached and remains in the patient.The chronic total occluded target lesion was located in the moderately tortuous and severely calcified anterior pedal loop artery.A savion flx was selected for use.During advancement to the lesion with heavy manipulation, the transition point at the tip of the wire broke off in the patients foot.Attempts to retrieve the wire tip were made using a snare, but were unsuccessful.The procedure was completed with another savion wire.There were no patient complications reported and the patients status post procedure was good.

• 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: 10437017
• Report Number: 2134265-2020-11444
• Device Sequence Number: 2795316
• 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
• Report Date (Section B): 08/21/2020

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: 07/07/2022
• Device Model Number: 1006
• Device Catalogue Number: 1006
• Device Lot Number: 0025683348
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention