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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 Break (1069); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/26/2022
Event Type  malfunction  
Event Description
It was reported that hypotube was fractured.A 10.0-31 carotid wallstent stent and a 190cm filterwire ez catheter were selected for use.During the preparation of the filter, it was noted that the hypotube fractured not allowing the delivery of the filter.The stent did not occur over the delivery wire.The procedure was completed with another of the same device.No patient complications were reported.
 
Event Description
It was reported that hypotube was fractured.A 10.0-31 carotid wallstent stent and a 190cm filterwire ez catheter were selected for use.During the preparation of the filter, it was noted that the hypotube fractured not allowing the delivery of the filter.The stent did not occur over the delivery wire.The procedure was completed with another of the same device.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.This carotid device is recommended for use with a 0.014 (0.36mm) guidewire as per carotid wallstent ifu.During the product analysis a boston scientific 0.014 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 kinks or damage to the delivery system.The device was returned with the stent in the correct position on the device.No issues were noted with the stent.
 
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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 Key15737562
MDR Text Key306178791
Report Number2124215-2022-44694
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 02/20/2023
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 Number0027679743
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/17/2022
Initial Date FDA Received11/04/2022
Supplement Dates Manufacturer Received02/02/2023
Supplement Dates FDA Received02/20/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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