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

Model Number	28211
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device broke off, requiring additional intervention for removal.A 6 fr x 11 cm.035 super sheath introducer sheath was selected for placement.During the procedure, there was no resistance noted when the super sheath device was advanced in the vessel.However, upon completion of the procedure, it was noted that the device broke under fluoroscopic visualization.An attempt was made to extract the foreign body using a non-boston scientific (non-bsc) snare, without success.The detached portion of the device remained in the common femoral artery.A non-bsc 7 fr femoral introducer was then replaced, followed by an 8 fr femoral introducer.The system was mounted on a 7 fr jr 3.5 guide catheter, also without success.Additionally, a non-bsc loop-shaped angioplasty guide was used, but after multiple failed attempts to retrieve the device, the procedure was terminated due to the high risk of associated vascular complications.The patient underwent open surgery to explore and retrieved the introducer sheath.The cardiac catheterization procedure was completed.The patient fully recovered post-procedure.

• 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: 23829396
• Report Number: 2124215-2025-87294
• Device Sequence Number: 13083494
• Product Code: DYB
• UDI-Device Identifier: 14543527202449
• UDI-Public: (01)14543527202449(17)260131(10)23B14B7
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2026
• Device Model Number: 28211
• Device Catalogue Number: 28211
• Device Lot Number: 23B14B7
• 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: 11/25/2025
• Initial Report FDA Received Date: 12/17/2025
• Date Device Manufactured: 02/13/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE - ASAHI SION BLUE; SNARE - MULTISNARE SYSTEM IN 4 AND 6 FR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female