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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS SD RENAL/BILIARY; CATHETER, BILIARY, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION EXPRESS SD RENAL/BILIARY; CATHETER, BILIARY, DIAGNOSTIC Back to Search Results
Model Number 20188
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/22/2024
Event Type  malfunction  
Event Description
It was reported that shaft break occurred.The target location was located in the mildly calcified and mildly tortuous renal artery.Two stents were used in the left renal artery and one in the right renal artery.A 7.0mmx15mmx150cm express sd renal/biliary stent was advanced for treatment.However, during insertion, the distal part of the shaft broke in the sheath.The device was pulled out intact, and the procedure was completed with a new express sd renal/biliary stent.No patient complications were reported.
 
Manufacturer Narrative
Returned product consisted of an express sd balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed kinks 28cm and 29cm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no damage or irregularities.Product analysis could not confirm any separation but did find kinks on the device.
 
Event Description
It was reported that shaft break occurred.The target location was located in the mildly calcified and mildly tortuous renal artery.Two stents were used in the left renal artery and one in the right renal artery.A 7.0mmx15mmx150cm express sd renal/biliary stent was advanced for treatment.However, during insertion, the distal part of the shaft broke in the sheath.The device was pulled out intact, and the procedure was completed with a new express sd renal/biliary stent.No patient complications were reported.
 
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Brand Name
EXPRESS SD RENAL/BILIARY
Type of Device
CATHETER, BILIARY, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18649145
MDR Text Key334738578
Report Number2124215-2024-06312
Device Sequence Number1
Product Code NIN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152607
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/21/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20188
Device Catalogue Number20188
Device Lot Number0029177873
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/06/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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