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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
Device Problems Positioning Failure (1158); Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/29/2020
Event Type  malfunction  
Event Description
It was reported that stent fracture occurred.A 20x80/10fr uni plus 75cm wallstent endoprosthesis was advanced for use.However, during deployment, the stent would not deploy and it was noted that the stent struts were fractured.The procedure was completed with another stent.There were no patient complications reported and the patient was fine.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was received with the stent in the correct position on the device.The stent deployed without resistance or issue experienced.The distal stent wires of the deployed stent were noted to be damaged.This type of damage is consistent with the stent encountering resistance during deployment.No other issues were noted with the stent.A visual and microscopic examination identified no damage or issues with the delivery system or shaft or tip of the device that could potentially have contributed to the complaint incident.Solidified media was noted on the tip of the device.No other issues were identified during the product analysis.
 
Event Description
It was reported that stent fracture occurred.A 20x80/10fr uni plus 75cm wallstent endoprosthesis was advanced for use.However, during deployment, the stent would not deploy and it was noted that the stent struts were fractured.The procedure was completed with another stent.There were no patient complications reported and the patient was fine.
 
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Brand Name
WALLSTENT ENDOPROSTHESIS
Type of Device
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9711258
MDR Text Key180123687
Report Number2134265-2020-01521
Device Sequence Number1
Product Code JCT
UDI-Device Identifier08714729204114
UDI-Public08714729204114
Combination Product (y/n)N
PMA/PMN Number
K152842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/23/2020
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 Expiration Date07/02/2021
Device Model Number26280
Device Catalogue Number26280
Device Lot Number0024051074
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2020
Initial Date Manufacturer Received 01/29/2020
Initial Date FDA Received02/14/2020
Supplement Dates Manufacturer Received03/11/2020
Supplement Dates FDA Received03/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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