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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SAVION FLX; WIRE, GUIDE, CATHETER
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BOSTON SCIENTIFIC CORPORATION SAVION FLX; WIRE, GUIDE, CATHETER Back to Search Results
Model Number 1006
Medical Device Problem Codes Detachment of Device or Device Component (2907); Material Integrity Problem (2978)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 02/26/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the guide wire tip detachment occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified posterior tibial artery.When a savion flx guidewire was navigated to the target lesion, the tip of the wire broke off in the patient's vessel and could not be removed.The procedure was completed with a non-bsc wire.No further patient complications were reported and the patient was doing well.
 
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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 Key11500049
Report Number2134265-2021-02930
Device Sequence Number19527331
Product Code DQX
UDI-Device Identifier08714729978817
UDI-Public08714729978817
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K180726
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 03/16/2021
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 Date10/01/2022
Device Model Number1006
Device Catalogue Number1006
Device Lot Number0026116766
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/26/2021
Initial Report FDA Received Date03/17/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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