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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SUPER SHEATH INTRODUCER SHEATH; INTRODUCER, CATHETER
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BOSTON SCIENTIFIC CORPORATION SUPER SHEATH INTRODUCER SHEATH; INTRODUCER, CATHETER Back to Search Results
Model Number 226
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/01/2020
Event Type  malfunction  
Event Description
It was reported that a wet film inside the sterile package was found.A wet film was noted inside the sterile packaging of a 6fx25cm super sheath introducer sheath.The oily residue was seen inside the package near the device hub.When the package was opened, it was almost oily when felt.No patient involvement was reported.
 
Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The actual item was returned in its unopened packaging.From visual inspection of the sterilization bag, it was confirmed that oil had adhered to the film part of the sterilization bag.Oil adhering to the inside of the film of the sterilization bag were investigated by fourier transform infrared spectroscopy (ft-ir) test, and it was confirmed that this oil was silicone oil applied to the hemostatic valve of the sheath.From inspection of the area around the sheath including the hemostatic valve, it was confirmed that silicone oil had adhered.Process of applying silicone oil to the hemostasis valve of the sheath was investigated, and it was confirmed that the silicone oil which was excessively put on the hemostasis valve was wiped off.
 
Event Description
It was reported that a wet film inside the sterile package was found.A wet film was noted inside the sterile packaging of a 6fx25cm super sheath introducer sheath.The oily residue was seen inside the package near the device hub.When the package was opened, it was almost oily when felt.No patient involvement was reported.
 
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Brand Name
SUPER SHEATH INTRODUCER SHEATH
Type of Device
INTRODUCER, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10304655
MDR Text Key199855641
Report Number2134265-2020-09577
Device Sequence Number1
Product Code DYB
UDI-Device Identifier14543527181522
UDI-Public14543527181522
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2022
Device Model Number226
Device Catalogue Number226
Device Lot Number19L04B6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/07/2020
Date Manufacturer Received09/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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