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

Model Number	28186
Medical Device Problem Codes	Difficult to Remove (1528); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sheath was difficult to remove.A 5fr introducer sheath was selected for use in a trans-arterial chemoembolization (tace) procedure.Vascular access was obtained via a puncture of the right common femoral artery (cfa).The introducer sheath was advanced into the artery over a standard 0.035 guidewire.A non-bsc diagnostic catheter was advanced over the guidewire and torqued 360 degrees.At this point it was observed that the catheter could not be retracted, and a guidewire could not pass through it.A 0.018 non-bsc guidewire was attempted for use, but was unsuccessful.The catheter was managed to be removed with difficulty, and a new.035 non-bsc guidewire was advanced into the aorta.It was then observed that the catheter was completely twisted on itself.The sheath was then removed, however, it was crumpled and difficult to remove.A new 5fr introducer sheath was selected for use.There was difficulty advancing the sheath into the vessel.The sheath was observed to have coiled up under the skin which resulted in a hematoma.A new 5fr sheath was selected for use.The procedure was then able to be completed without further incident.There were no further patient consequences.The patient was expected to fully recover.
Event or Problem Description
It was reported that the sheath was difficult to remove.A 5fr introducer sheath was selected for use in a trans-arterial chemoembolization (tace) procedure.Vascular access was obtained via a puncture of the right common femoral artery (cfa).The introducer sheath was advanced into the artery over a standard 0.035 guidewire.A non-bsc diagnostic catheter was advanced over the guidewire and torqued 360 degrees.At this point it was observed that the catheter could not be retracted, and a guidewire could not pass through it.A 0.018 non-bsc guidewire was attempted for use, but was unsuccessful.The catheter was managed to be removed with difficulty, and a new.035 non-bsc guidewire was advanced into the aorta.It was then observed that the catheter was completely twisted on itself.The sheath was then removed, however, it was crumpled and difficult to remove.A new 5fr introducer sheath was selected for use.There was difficulty advancing the sheath into the vessel.The sheath was observed to have coiled up under the skin which resulted in a hematoma.A new 5fr sheath was selected for use.The procedure was then able to be completed without further incident.There were no further patient consequences.The patient was expected to fully recover.
Additional Manufacturer Narrative
Device eval by mfr: the device was returned and analysis completed.A 5fr introducer sheath was received for technical analysis.A sheath, dilator, guidewire and non-boston scientific angiographic catheter were returned.Visual examination revealed that the sheath was deformed in a bellows-like appearance over a 50mm area from the sheath tip and that the base of the sheath had also been deformed in the same way.The non-bsc catheter was stretched out and collapsed from 40 mm to 180 mm from the tip of the catheter.

• 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: 18268060
• Report Number: 2124215-2023-67195
• Device Sequence Number: 19821950
• Product Code: DYB
• UDI-Device Identifier: 14543527181799
• UDI-Public: 14543527181799
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2024

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: 03/31/2026
• Device Model Number: 28186
• Device Catalogue Number: 28186
• Device Lot Number: 23D17B3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2023
• 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
• Patient Sex: Unknown