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

Model Number 220

Device Problem Entrapment of Device (1212)

Patient Problems Hemorrhage/Bleeding (1888); Vascular Dissection (3160)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

Age at time of event - 18 years or older.

Event 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
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): MEDIKIT COMPANY LIMITED; 13-2 yushima 1-chome; bunkyo-ku tokyo 113 ; JA 113
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10897154
• MDR Text Key: 218242881
• Report Number: 2134265-2020-16316
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 14543527181409
• UDI-Public: 14543527181409
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2020
• Initial Date FDA Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other