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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA; STENT, SUPERFICIAL FEMORAL ARTERY
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BOSTON SCIENTIFIC CORPORATION INNOVA; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Model Number 26920
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/30/2021
Event Type  malfunction  
Event Description
It was reported that a hair was found in the sterile packaging.The target lesion was located in the superficial femoral artery (sfa).An 6x150x130 innova was selected for use.A hair was found inside the sterile packaging.There were no anomalies noted with the packaging prior to use and the packaging was intact.Another of the same device was used to complete the procedure and it was fine.There were no patient complications.
 
Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an innova self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed two pieces of what appears to be hair on the tray.Microscopic examination revealed no additional damages.Inspection of the remainder of the device, revealed no other damage or irregularities.
 
Event Description
It was reported that a hair was found in the sterile packaging.The target lesion was located in the superficial femoral artery (sfa).An 6x150x130 innova was selected for use.A hair was found inside the sterile packaging.There were no anomalies noted with the packaging prior to use and the packaging was intact.Another of the same device was used to complete the procedure and it was fine.There were no patient complications.
 
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Brand Name
INNOVA
Type of Device
STENT, SUPERFICIAL FEMORAL ARTERY
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13351615
MDR Text Key284881560
Report Number2134265-2022-00475
Device Sequence Number1
Product Code NIP
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/19/2023
Device Model Number26920
Device Catalogue Number26920
Device Lot Number0026207621
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received03/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/19/2020
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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