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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT-UNI ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE
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BOSTON SCIENTIFIC CORPORATION WALLSTENT-UNI ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE Back to Search Results
Model Number 26650
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2022
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.A 10 x 68mm x 75cm wallstent-uni endoprosthesis was selected for use.When the physician opened the stent during preparation, shaft break was noted.The break was located 42.5cm from the hub.The device was set aside and another 10 x 68mm x 75cm wallstent-uni endoprosthesis was used to complete the procedure.There were no patient complications reported and the patient status was stable.
 
Event Description
It was reported that shaft break occurred.A 10 x 68mm x 75cm wallstent-uni endoprosthesis was selected for use.When the physician opened the stent during preparation, shaft break was noted.The break was located 42.5cm from the hub.The device was set aside and another 10 x 68mm x 75cm wallstent-uni endoprosthesis was used to complete the procedure.There were no patient complications reported and the patient status was stable.
 
Manufacturer Narrative
Device evaluated by mfr.: a wallstent uni was returned for analysis.The device was returned with the stent fully mounted in the correct location on the device.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified that the shaft was fractured approximately 290mm distal from the distal tip.
 
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Brand Name
WALLSTENT-UNI ENDOPROSTHESIS
Type of Device
PROSTHESIS, TRACHEAL, EXPANDABLE
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 Key15982050
MDR Text Key307889201
Report Number2124215-2022-50942
Device Sequence Number1
Product Code JCT
Combination Product (y/n)N
Reporter Country CodeIS
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 02/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/24/2023
Device Model Number26650
Device Catalogue Number26650
Device Lot Number0028445496
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/24/2021
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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