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

Model Number	220
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Vascular Dissection (3160)
Date of Event	09/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event - 18 years or older.
Event or Problem Description
It was reported that the device locked on the wire and a dissection occurred.A 5f x 11cm super sheath introducer sheath with 0.038in mini guidewire was selected for use in a procedure within the femoral artery.The post-dilated target lesion was 300mm long with no calcification.During the procedure, the mini guidewire locked on to the non-boston scientific introducer needle.The super sheath introducer sheath was never advanced inside the body; only the mini guidewire that was provided with the device was inside the body.There was bleeding from a small rift in the vessel that required extra hand compression.The procedure was completed with another of the same device.No other patient complications were reported.

• Brand Name: SUPER SHEATH INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10897154
• Report Number: 2134265-2020-16316
• Device Sequence Number: 14204619
• Product Code: DYB
• UDI-Device Identifier: 14543527181409
• UDI-Public: 14543527181409
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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: 12/31/2022
• Device Model Number: 220
• Device Catalogue Number: 220
• Device Lot Number: 20A16BA
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other