MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION GLIDESHEATH SLENDER; INTRODUCER, CATHETER

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/07/2021

Event Type  Injury  

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation - supply coordinator.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.

Event Description

The user facility reported that a neuro procedure, diagnostic cerebral, was performed via a glide-sheath slender.The physician had radial access and advanced the wire within the needle which comes in the kit.The physician tried to withdraw the needle and part of wire came out with the needle.The brite nitinol tip of the wire stayed inside the arm.The physician abandoned radial access and used cook micro puncture set via femoral.The patient had retained foreign body which resulted in surgery cut down to remove fbv.The patient condition and procedure outcome are unknown.Additional information received on (b)(6) 2021: wire was successfully removed during surgery.

Manufacturer Narrative

This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.A review of the device history record of the product code/lot# combination was conducted with no findings.One 5fr glidesheath slender guidewire was returned for product evaluation.The returned guidewire was subject to visual analysis, and it was observed that the guidewire was broken and contained a region of open coil near the broken end.The portion of the guidewire that was retained in the patient was not returned, but the site contact confirmed that it was successfully removed from the patient.Dimensional testing was performed.The returned guidewire was measured to be 41cm long.The guidewire length specification is 42.8cm to 44cm.The only region of coil on the guidewire was from 3.3cm to 3.9cm from the separated end of the guidewire and appeared to be deformed.This is consistent with where the epoxy region of the guidewire should be according to the manufacturer's specifications.From 3.3cm to the separated end of the guidewire, the coil was open.The diameter of the proximal shaft of the guidewire was measured to be 0.206in.The specification of the part is 0.205in to 0.210in.The diameter of the distal end of the guidewire was not measured due to the state of the sample.The complaint can be confirmed for guidewire mechanical separation as the sample was broken near the floppy end it's short length.The exact root cause could not be determined.The device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the fmea.

• Brand Name: GLIDESHEATH SLENDER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: mary o'neill ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 13112880
• MDR Text Key: 282955221
• Report Number: 1118880-2021-00219
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00389701011363
• UDI-Public: 00389701011363
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173831
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 50-1050
• Device Lot Number: 0000034506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2021
• 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
• Treatment: COOK MICRO PUNCTURE SET
• Patient Outcome(s): Other; Required Intervention