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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 No Code Available (3191)
Date of Event 04/01/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Aware date is an estimated date based off the notification date as the exact aware date was not reported.Date of event: no date provided, used the first date in the month of the aware date.
 
Event or Problem Description
It was reported that a detachment occurred.A savion flx guidewire was selected for use.During the procedure, the guidewire buckled on the unspecified balloon catheter and snapped off inside the patient.A snare was used to remove the guidewire.There were no 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 Key10051694
Report Number2134265-2020-06357
Device Sequence Number2835608
Product Code DQX
UDI-Device Identifier08714729978824
UDI-Public08714729978824
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
PMA/510(K) Number
K180726
Number of Events Summarized1
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) 05/13/2020
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 Date02/04/2022
Device Model Number1006
Device Catalogue Number1006
Device Lot Number0025165428
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/22/2020
Initial Report FDA Received Date05/13/2020
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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