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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/20/2021
Event Type  Injury  
Event Description
It was reported that the device got caught in the distal edge of the stent, fragment moved in the distal and was retrieved with a snare.The 80% stenosed target lesion was located in the internal carotid artery and common carotid artery.A 190cm filterwire ez and a wallstent were selected for use.During the procedure, a sterling and wallstent10-31 were used upon pre and post dilation.The filter became "slow flow" and it could not fit in the catheter for total retrieval.When 80% was retrieved, the device got caught in the distal edge of the wallstent.The device was removed carefully and the physician then noticed that part of the filter bag was missing.A possibility that the fragment moved to the distal side.The guiding was replaced with a cutting balloon and after aspiration, an imaging was performed and it was noted that the filter moved in the edge of the stent.The fragment was removed using a snare.A distal was not observed through ct scan.However, it will be checked again with mri the next day.No further patient complications were reported.
 
Manufacturer Narrative
(b)(6).
 
Manufacturer Narrative
E1 - initial reporter facility name: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed.Only the filterwire distal section was received.The spring tip was observed bent, stretched and curvy and the filter was ripped.No other issues or anomalies were observed.Microscopic inspection was performed.Under microscope inspection, the filter and distal section were inspected and the spring tip was observed bent, stretched and curvy and the filter was ripped.Additionally, the wire shows evidence of a mechanical cut.Media inspection of the provided photos revealed that only the filter at distal section was visible.The filter was ripped.No other issues were observed.
 
Event Description
It was reported that the device got caught in the distal edge of the stent, fragment moved in the distal and was retrieved with a snare.The 80% stenosed target lesion was located in the internal carotid artery and common carotid artery.A 190cm filterwire ez and a wallstent were selected for use.During the procedure, a sterling and wallstent10-31 were used upon pre and post dilation.The filter became "slow flow" and it could not fit in the catheter for total retrieval.When 80% was retrieved, the device got caught in the distal edge of the wallstent.The device was removed carefully and the physician then noticed that part of the filter bag was missing.A possibility that the fragment moved to the distal side.The guiding was replaced with a cutting balloon and after aspiration, an imaging was performed and it was noted that the filter moved in the edge of the stent.The fragment was removed using a snare.A distal was not observed through ct scan.However, it will be checked again with mri the next day.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 Key13238795
MDR Text Key283752621
Report Number2134265-2022-00003
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
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2022
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? Device Returned to Manufacturer
Date Returned to Manufacturer01/20/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/02/2022
Was Device Evaluated by Manufacturer? Yes
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
GUIDING CATHETER - 8F LAUNCHER MEDTRONIC; GUIDING CATHETER - 8F LAUNCHER MEDTRONIC; INTRODUCER SHEATH - 8F MEDIKIT; INTRODUCER SHEATH - 8F MEDIKIT
Patient Outcome(s) Required Intervention;
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