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

Model Number	28180
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the sheath separated inside the body and additional intervention was needed to remove the fragment.This super sheath introducer sheath 6 fr x 11 cm.035 was selected for patent foramen ovale (pfo) procedure with an experienced cardiologist.Preparation of the sheath was flushed/completed and showed no abnormality.During the procedure, upon the second use, the operator had difficulty removing the sheath from the vessel causing the sheath to separate inside the patient.Additional intervention was performed to open the vessel and remove the broken sheath fragment from the patient.During the intervention, the patient lost a lot of blood.The patient had a prolonged hospitalization; however, was expected to fully recover.Another super sheath was used to complete the procedure.
Additional Manufacturer Narrative
Device eval by manufacturer: the super sheath introducer sheath was received in two pieces.Visual inspection confirmed the sheath tube was broken at a position of about 10 mm from the sheath base.Additionally, kinks were identified at five locations: 30mm, 55mm, 65mm, 80mm, and 85mm from the tip of the sheath.Microscopic inspection of the torn-off portion confirmed that part of the fractured surface might have been created by a sharp instrument and the rest of the fractured surface was further torn apart when the sheath pulled off during the procedure.
Event or Problem Description
It was reported that the sheath separated inside the body and additional intervention was needed to remove the fragment.This super sheath introducer sheath 6 fr x 11 cm.035 was selected for patent foramen ovale (pfo) procedure with an experienced cardiologist.Preparation of the sheath was flushed/completed and showed no abnormality.During the procedure, upon the second use, the operator had difficulty removing the sheath from the vessel causing the sheath to separate inside the patient.Additional intervention was performed to open the vessel and remove the broken sheath fragment from the patient.During the intervention, the patient lost a lot of blood.The patient had a prolonged hospitalization; however, was expected to fully recover.Another super sheath was used to complete the 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: 19622758
• Report Number: 2124215-2024-39009
• Device Sequence Number: 6334579
• Product Code: DYB
• UDI-Device Identifier: 14543527181584
• UDI-Public: 14543527181584
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Followup
• Report Date (Section B): 09/24/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 28180
• Device Catalogue Number: 28180
• Device Lot Number: 24A17B8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 100 KG