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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC
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BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC Back to Search Results
Model Number 20226
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Patient Involvement (2645)
Event Date 08/18/2020
Event Type  malfunction  
Event Description
It was reported that stent dislodgement occurred.A 8.0x40x135 cm express ld stent was opened during preparation.However, the stent slid off the balloon and dislodged from the catheter when removing the protective cover over the stent.The procedure was completed with another of the same device.There were no patient complications reported.
 
Event Description
It was reported that stent dislodgement occurred.A 8.0x40x135 cm express ld stent was opened during preparation.However, the stent slid off the balloon and dislodged from the catheter when removing the protective cover over the stent.The procedure was completed with another of the same device.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr: an express ld device was returned for analysis.The stent was not received.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.A visual and microscopic examination identified no issues with the balloon material that could have contributed to the complaint incident.A visual and microscopic examination identified no issues with the tip of the device during analysis that could have contributed to the complaint incident.A visual and tactile examination identified no damage or any issues along the length of the device.No other issues were identified during the product analysis.
 
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Brand Name
EXPRESS LD ILIAC / BILIARY
Type of Device
STENT, ILIAC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10689885
MDR Text Key211662384
Report Number2134265-2020-14318
Device Sequence Number1
Product Code NIO
UDI-Device Identifier08714729392477
UDI-Public08714729392477
Combination Product (y/n)N
PMA/PMN Number
K133110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/03/2023
Device Model Number20226
Device Catalogue Number20226
Device Lot Number0025296641
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/24/2020
Date Manufacturer Received12/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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