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

Model Number	28186
Medical Device Problem Codes	Difficult to Insert (1316); Use of Device Problem (1670)
Health Effect - Clinical Codes	Extravasation (1842); Pain (1994)
Date of Event	02/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the sheaths were difficult to advance through the skin resulting in pain and perinephric urinoma was treated medically.Two 9 fr x 11 cm super sheath introducer sheaths of the same lot were used during this antegrade ureteric stenting of the right kidney.It was reported that the sheaths were difficult to advance through the skin to the right kidney causing a lot of pain to the right side of the back access point.The radiologist dilated up to a 10 fr dilator (using dilators - 6,7,8,9,10) to aid dilation of the track for the 9 fr sheath placement with difficulty.The stent was successfully placed.As a result of the pain, the patient was treated immediately post-procedure with paracetamol, ibuprofen and iv fentanyl.The patient had progressive worsening pain, and a ct scan revealed an extravasation of contrast in keeping with a perinephric urinoma which may have been contributed to by the sheath or the associated dilatation required to insert it.The patient was referred to urology for inpatient admission for ongoing observation and pain management, iv fluids.The patient had some urinary retention related to their bladder outflow obstruction that resulted in worsening renal function.During monitoring of observations, the patient's vitals remained stable, and the patient was discharged with a follow-up appointment.
Event or Problem Description
It was reported that the sheaths were difficult to advance through the skin resulting in pain and perinephric urinoma was treated medically.Two 9 fr x 11 cm super sheath introducer sheaths of the same lot were used during this antegrade ureteric stenting of the right kidney.It was reported that the sheaths were difficult to advance through the skin to the right kidney causing a lot of pain to the right side of the back access point.The radiologist dilated up to a 10 fr dilator (using dilators - 6,7,8,9,10) to aid dilation of the track for the 9 fr sheath placement with difficulty.The stent was successfully placed.As a result of the pain, the patient was treated immediately post-procedure with paracetamol, ibuprofen and iv fentanyl.The patient had progressive worsening pain, and a ct scan revealed an extravasation of contrast in keeping with a perinephric urinoma which may have been contributed to by the sheath or the associated dilatation required to insert it.The patient was referred to urology for inpatient admission for ongoing observation and pain management, iv fluids.The patient had some urinary retention related to their bladder outflow obstruction that resulted in worsening renal function.During monitoring of observations, the patient's vitals remained stable, and the patient was discharged with a follow-up appointment.

• 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: 21607191
• Report Number: 2124215-2025-15472
• Device Sequence Number: 9217788
• Product Code: DYB
• UDI-Device Identifier: 14543527181836
• UDI-Public: 14543527181836
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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: 06/30/2026
• Device Model Number: 28186
• Device Catalogue Number: 28186
• Device Lot Number: 23G24B7
• 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: 02/14/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 07/18/2025
• Date Device Manufactured: 07/24/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown