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

Model Number	220
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Event or Problem 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 7fx11cm 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.
Additional 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 or Problem 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 7fx11cm 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.

• 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: 10314183
• Report Number: 2134265-2020-09763
• Device Sequence Number: 16946283
• Product Code: DYB
• UDI-Device Identifier: 14543527181423
• UDI-Public: 14543527181423
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

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: 08/31/2022
• Device Model Number: 220
• Device Catalogue Number: 220
• Device Lot Number: 19I26B8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Received by Manufacturer: 07/10/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1