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

Model Number	28185
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a hole in the sheath occurred.A 7 fr x 25 cm super sheath introducer sheath was placed into the arm over the wire for treating slow flow fistula procedure.The wire was removed and took an angiography of the arm by injecting the contrast through the sheath.However, the contrast was found coming out of the tip of the sheath.Another contrast was shot, and it was confirmed that the contrast was coming out in the middle part of the sheath.The device was removed and found a hole in it.Another sheath of the same size and type was used to complete the procedure.There were no patient complications as a result of this event, and the patient was stable.

• Brand Name: SUPER SHEATH INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): MEDIKIT COMPANY LIMITED; 13-2 yushima 1-chome; bunkyo-ku tokyo 113-0 034; JA 113-0034
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21854136
• Report Number: 2124215-2025-23260
• Device Sequence Number: 15614003
• Product Code: DYB
• UDI-Device Identifier: 14543527181706
• UDI-Public: 14543527181706
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/17/2025

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: 12/31/2024
• Device Model Number: 28185
• Device Catalogue Number: 28185
• Device Lot Number: 22A19B4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Initial Report FDA Received Date: 04/17/2025
• Date Device Manufactured: 01/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Race: White