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

Model Number	28211
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a foreign material was present inside the device packaging.A 5frx11cm.035 super sheath introducer sheath was selected for use.During unpacking, when the device was opened, it was noticed that a hair was inside the packaging.No patient complications were 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: 9937997
• Report Number: 2134265-2020-04642
• Device Sequence Number: 654784
• Product Code: DYB
• UDI-Device Identifier: 14543527202432
• UDI-Public: 14543527202432
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 04/08/2020

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: 10/31/2022
• Device Model Number: 28211
• Device Catalogue Number: 28211
• Device Lot Number: 19K08B1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 04/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR