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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID
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BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID Back to Search Results
Model Number 26605
Device Problems Entrapment of Device (1212); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: the true event date was not reported.The first day of the month of the aware date was used as an estimate.Implant date: estimated.
 
Event Description
It was reported that removal difficulty occurred.A carotid wallstent was advanced to the stenosed carotid artery over a non boston scientific guidewire and deployed without issue.After release of the stent, it was not possible to remove the catheter via the guidewire.The physician removed the catheter and guidewire together.There were no patient complications and the procedure was completed successfully.
 
Manufacturer Narrative
B2 - date of event: the true event date was not reported.The first day of the month of the aware date was used as an estimate.D6a - implant date: estimated.H3 - device evaluated by manufacturer: the device was received with the guidewire inserted in the device which was unable to be removed.Multiple kinks were identified along the length of the guidewire.A visual and tactile examination of the catheter identified multiple shaft kinks.The stent was deployed and not returned with the delivery system.No other issues were identified during the product analysis.
 
Event Description
It was reported that removal difficulty occurred.A carotid wallstent was advanced to the stenosed carotid artery over a non boston scientific guidewire and deployed without issue.After release of the stent, it was not possible to remove the catheter via the guidewire.The physician removed the catheter and guidewire together.There were no patient complications and the procedure was completed successfully.
 
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Brand Name
CAROTID WALLSTENT
Type of Device
STENT, CAROTID
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key12089192
MDR Text Key259147642
Report Number2134265-2021-08130
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number26605
Device Catalogue Number26605
Device Lot Number0027377746
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2021
Initial Date Manufacturer Received 06/16/2021
Initial Date FDA Received06/29/2021
Supplement Dates Manufacturer Received07/23/2021
Supplement Dates FDA Received08/10/2021
Patient Sequence Number1
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