Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT-UNI ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION WALLSTENT-UNI ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE Back to Search Results
Model Number 26650
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/22/2023
Event Type  malfunction  
Event Description
It was reported that tip detachment occurred.During unpacking, a 18 x 60mm x 75cm wallstent-uni endoprosthesis was selected for use.During unpacking, it was noticed that the small transparent tip was missing at the end where the stent comes out.A lot of force was then applied to get the stent out and eventually the transparent tip came out with the risk of being released with the stent.The procedure was completed using an alternative device, and no patient complications were reported.
 
Event Description
It was reported that tip detachment occurred.During unpacking, a 18 x 60mm x 75cm wallstent-uni endoprosthesis was selected for use.During unpacking, it was noticed that the small transparent tip was missing at the end where the stent comes out.A lot of force was then applied to get the stent out and eventually the transparent tip came out with the risk of being released with the stent.The procedure was completed using an alternative device, and no patient complications were reported.
 
Manufacturer Narrative
E1 - initial reporter phone: (b)(6).Device analysis: a wallstent uni 18 x 60mm x 75cm was received for analysis.The device was returned with the stent in the correct position on the delivery system.A visual and tactile examination identified no issues with the tip or shaft of the device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
WALLSTENT-UNI ENDOPROSTHESIS
Type of Device
PROSTHESIS, TRACHEAL, EXPANDABLE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16566601
MDR Text Key311516459
Report Number2124215-2023-09996
Device Sequence Number1
Product Code JCT
Combination Product (y/n)N
Reporter Country CodeFR
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 05/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number26650
Device Catalogue Number26650
Device Lot Number0030673411
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-