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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 Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 01/19/2021
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that tip detachment and unretrieved device fragment occurred.The 95% stenosed target lesion was located in the severely tortuous and severely calcified distal posterior tibial artery.A savion flx guidewire was advanced, however; the tip broke off in the distal posterior side branch.The physician did not attempt to retrieve the detached tip due to the tip being small.The procedure was cancelled.There were no further patient complications reported.
 
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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 Key11259644
Report Number2134265-2021-00956
Device Sequence Number13650643
Product Code DQX
UDI-Device Identifier08714729978817
UDI-Public08714729978817
Combination Product (Y/N)N
Initial Reporter StateNY
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 Other
Type of Report Initial
Report Date (Section B) 02/01/2021
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 Date09/29/2022
Device Model Number1006
Device Catalogue Number1006
Device Lot Number0026099512
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 01/19/2021
Initial Report FDA Received Date02/01/2021
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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