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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 28186
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 02/13/2020
Event Type  malfunction  
Event Description
Boston scientific received an unused and unopened package with no reported allegation from the healthcare facility.Upon initial observation, it was observed that there was fluid at the hub of the device inside the sterile package.
 
Manufacturer Narrative
Device evaluated by manufacturer: the product was returned inside the sealed sterile pouch.Visual examination confirmed moisture was adhered to the inside of the sterile pouch.Further examination confirmed that the moisture was silicone oil.Silicone oil was also observed surrounding the hemostatic valve.Silicone oil is used during the manufacturing process and applied to the hemostatic valve.The oil facilitates smooth operation of the valve during use.The amount of silicone oil applied to the hemostatic valve is minimal, but not constant.If manufacturing personnel determines that excess silicone oil has been applied during the set-up of the sheath and dilator, or if silicone oil deposits are observed in areas that come into contact with the sterilization bag before the product is placed in the sterilization bag, the manufacturing procedure requires to wipe off the silicone oil deposits.In addition, final visual inspection of foreign material is conducted at the package to shelf carton.It is thought that the silicone oil applied to the sheath valve came into contact with the inner sterile pouch due to vibration during transportation and storage condition.
 
Event Description
Boston scientific received an unused and unopened package with no reported allegation from the healthcare facility.Upon initial observation, it was observed that there was fluid at the hub of the device inside the sterile package.
 
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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 Key10030913
MDR Text Key190520268
Report Number2134265-2020-06090
Device Sequence Number1
Product Code DYB
UDI-Device Identifier14543527181805
UDI-Public14543527181805
Combination Product (y/n)N
PMA/PMN Number
K060190
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2022
Device Model Number28186
Device Catalogue Number28186
Device Lot Number19J01B6
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2020
Date Manufacturer Received05/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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