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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number 26280
Medical Device Problem Code Positioning Problem (3009)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/28/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
 
Event or Problem Description
It was reported that positioning problems were encountered.The 60-80% stenosed target lesion was located in the moderately tortuous and non-calcified inferior vena cava (ivc).A 75cm 18x60/10fr uni plus wallstent endoprosthesis was advanced; however, the device jumped to different location than the physician was meant to deploy from the ivc to the renal vein.The procedure was completed with the original device.No patient complications were reported and the patient's status was stable.
 
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Brand Name
WALLSTENT ENDOPROSTHESIS
Common Device Name
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11855914
Report Number2134265-2021-06252
Device Sequence Number1021411
Product Code JCT
UDI-Device Identifier08714729204077
UDI-Public08714729204077
Combination Product (Y/N)N
Initial Reporter CountryTW
PMA/510(K) Number
K152842
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/20/2021
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
Operator of Device Health Professional
Device Expiration Date07/21/2022
Device Model Number26280
Device Catalogue Number26280
Device Lot Number0025745081
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/28/2021
Initial Report FDA Received Date05/20/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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