MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SUPER SHEATH INTRODUCER SHEATH; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	28205
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Sepsis (2067)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced hypotension and became septic requiring admittance to intensive care unit and prolonged hospitalization.A 12 fr x 25 cm super sheath introducer sheath was selected for use in a non-stenosed vessel for a percutaneous cholangioscopy procedure.During the procedure, while irrigating the biliary system with saline, the introducer sheath did not allow for adequate pressure to be released.As a result, the patient became hypotensive and septic after the procedure, requiring admittance to the intensive care unit (icu).The procedure was completed with this device.The patient has recovered and has been discharged.
Additional Manufacturer Narrative
B3 - date of event: date of event was approximated to 04/01/2024 as the exact event date was not reported.

• Brand Name: SUPER SHEATH INTRODUCER SHEATH
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 13-2 yushima 1-chome; bunkyo-ku tokyo ; JA
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19350303
• Report Number: 2124215-2024-26556
• Device Sequence Number: 12613226
• Product Code: DRE
• UDI-Device Identifier: 14543527202012
• UDI-Public: 14543527202012
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 05/20/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 28205
• Device Catalogue Number: 28205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other; Hospitalization
• Patient Sex: Unknown