MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SUPER SHEATH INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number	28186
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/13/2020
Type of Reportable Event	Malfunction
Event or Problem 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.
Event or Problem 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.
Additional 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.

• Brand Name: SUPER SHEATH INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10035773
• Report Number: 2134265-2020-06147
• Device Sequence Number: 19579726
• Product Code: DYB
• UDI-Device Identifier: 14543527181805
• UDI-Public: 14543527181805
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K060190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 28186
• Device Catalogue Number: 28186
• Device Lot Number: 19J01B6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2020
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 05/16/2020
• Initial Report FDA Received Date: 05/07/2020
• Supplement Report FDA Received Date: 06/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1