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

Model Number	28186
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via user facility medwatch report # mw5079066 that a sheath fracture occurred.A 8fr x 11cm n/g super sheath introducer sheath was selected for use.During the procedure, it was noted that during vascular access, the sheath fractured with active extravasation around the sheath entry site.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: 7865485
• Report Number: 2134265-2018-60861
• Device Sequence Number: 1964119
• Product Code: DYB
• UDI-Device Identifier: 14543527181829
• UDI-Public: 14543527181829
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K060190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/11/2018

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: 01/31/2021
• Device Model Number: 28186
• Device Catalogue Number: 28186
• Device Lot Number: 18B19B5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1