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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 Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/25/2022
Event Type  malfunction  
Event Description
It was reported that catheter entrapment occurred.The target lesion was located in the right internal carotid artery.After a filterwire reached the targeted position, a 10.0-31 carotid monorail stent was unpacked, primed and flushed.When the physician advanced the stent into the guiding catheter through the filterwire from the monorail port of the stent, a large resistance was encountered and could not continue to advance.The physician withdrew the stent and filterwire together from the patient at a fully reconstrained state and found the stent become stuck with the filterwire out of the patient.The stent was removed from the filterwire by simply pulling it out.The procedure was completed with a different device.There were no complications reported and the patient is stable.
 
Event Description
It was reported that catheter entrapment occurred.The target lesion was located in the right internal carotid artery.After a filterwire reached the targeted position, a 10.0-31 carotid monorail stent was unpacked, primed and flushed.When the physician advanced the stent into the guiding catheter through the filterwire from the monorail port of the stent, a large resistance was encountered and could not continue to advance.The physician withdrew the stent and filterwire together from the patient at a fully reconstrained state and found the stent become stuck with the filterwire out of the patient.The stent was removed from the filterwire by simply pulling it out.The procedure was completed with a different device.There were no complications reported and the patient is stable.
 
Manufacturer Narrative
Device evaluated by mfr.: carotid wallstent monorail 10.0-31 was received for analysis.This carotid device is recommended for use with a 0.014 guidewire as per carotid wallstent instructions for use (ifu).During the product analysis a boston scientific filterwire was successfully inserted through this device with no resistance experienced.The guidewire used by the customer was not returned for analysis.A visual and tactile examination identified no issues with the catheter or delivery system that could potentially have contributed to the complaint incident.The device was returned with the stent in the correct position on the device.No issues were noted with the stent that could potentially have contributed to the complaint incident.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key14461568
MDR Text Key292369137
Report Number2134265-2022-05342
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeCH
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,Followup
Report Date 08/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2022
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 Number0027793822
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/09/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/06/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age74 YR
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