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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FILTERWIRE EZ; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
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BOSTON SCIENTIFIC CORPORATION FILTERWIRE EZ; TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE Back to Search Results
Model Number 44150
Device Problems Difficult to Remove (1528); Material Integrity Problem (2978)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/20/2022
Event Type  Injury  
Event Description
It was reported that the filterwire became detached and remained inside the patient's body.A 190cm filterwire was selected for use in the internal carotid artery.During the procedure, after the placement of a non-boston scientific carotid stent, the recovery sheath was delivered to retrieve the filterwire, but resistance was felt in the stent.When the recovery sheath was removed, the tip marker could not be confirmed.It is highly likely that the tip of the sheath was damaged in the stent.The vent-tip sheath was opened and an attempt was made to retrieve the filterwire, but it could not be advanced distally from within the stent.Measures were taken such as advancing the dd6 proximal to the stent and advancing the vent tip, but still could not reach the filterwire.Therefore, an attempt was made to remove the filterwire and vent tip intact, but the filterwire detached from the delivery wire in the stent.The procedure was completed by crimping the remaining filter in the stent with a wall stent.No further patient complications were reported.
 
Event Description
It was reported that the filterwire became detached and remained inside the patient's body.A 190cm filterwire was selected for use in the internal carotid artery.During the procedure, after the placement of a non-boston scientific carotid stent, the recovery sheath was delivered to retrieve the filterwire, but resistance was felt in the stent.When the recovery sheath was removed, the tip marker could not be confirmed.It is highly likely that the tip of the sheath was damaged in the stent.The vent-tip sheath was opened and an attempt was made to retrieve the filterwire, but it could not be advanced distally from within the stent.Measures were taken such as advancing the dd6 proximal to the stent and advancing the vent tip, but still could not reach the filterwire.Therefore, an attempt was made to remove the filterwire and vent tip intact, but the filterwire detached from the delivery wire in the stent.The procedure was completed by crimping the remaining filter in the stent with a wall stent.No further patient complications were reported.
 
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Brand Name
FILTERWIRE EZ
Type of Device
TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
2546 calle primera
alajuela
CS  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13530164
MDR Text Key285620559
Report Number2134265-2022-01537
Device Sequence Number1
Product Code NTE
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 02/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/09/2023
Device Model Number44150
Device Catalogue Number44150
Device Lot Number0028173724
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
CAROTID STENT - PRECISE; GUIDING CATHETER - OPTIMO 9FR
Patient Outcome(s) Required Intervention;
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