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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record of the product code/lot number combination was conducted with no findings.The complaint can be confirmed for guidewire separation because the patient required follow up surgery.The exact root cause could not be determined.The complaint descriptions mentions that there was difficulty advancing the guidewire.The guidewire may have become stuck or damaged at this point which could have caused it to separate during withdrawal.Review of device history record (dhr) showed there were no issues noted during manufacture of the product that could have contributed to this complaint condition.Currently no action is recommended since this risk evaluation is within the predetermined limits in the design failure mode & effects analysis (dfmea).
Event or Problem Description
Terumo medical received a user facility medwatch report # 4600040000-2022-8015.The event description states: doctor was attempting to obtain right radial access, he had difficulty advancing the microwire and was removing it when the wire unraveled and broke off in right radial artery.Two other doctors called for assistance.The second doctor attempted to snare the wire, however, was unsuccessful.The patient was then added to the third doctors surgical schedule for surgical wire removal.No variance from typical workflow and or standard of care noted.Description of the third doctor's procedure: the patient was brought to the operating room and laid supine on the table.After monitored anesthesia care was administered, the right upper extremity was then prepped and draped in standard surgical fashion.The patient was given antibiotics prior to incision.Using fluoroscopy, the right wrist was imaged in the wire was identified within the distal left forearm region.A small longitudinal incision was made overlying the radial artery at this site after injecting 0.5% marcaine with epinephrine.Dissection was carried down through the subcutaneous tissue with the bovie cautery.The fascia overlying the radial artery was incised and the radial artery was identified and sharply dissected.The dissection more towards the wrist identified the wire to be exiting the artery.This was grasped.Dissection was carried down further where the puncture site was given by the wire came out of the puncture site.Wire was then grasped and slowly dragged out.Tip of the wire as well as the unraveling of the remainder of the wire was all excised out.It was taken out.The puncture site was closed with a 6-0 prolene suture in a figure-of-eight.There was good doppler signal noted within the radial artery proximally and distally.Hemostasis was achieved with thrombin gelfoam as well as bovie cautery.Papaverine was injected around the radial artery to relieve vasospasm.The overlying subcutaneous tissues were reapproximated with 3-0 vicryl suture in running fashion followed by closure of the skin with a 4-0 monocryl suture in subcuticular fashion.The area was cleansed and dried.Sterile dressings were applied.The patient tolerated the procedure well without any complications.Surgeon (third doctor) was present for the entire case.
Event or Problem Description
Terumo tmc performed a maude search on 31jan2023.Report number 15893119 was found and was confirmed to be of the same reported event, and therefore the maude report has been provided.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to provide the maude report.

• Brand Name: GLIDESHEATH SLENDER
• Common Device Name: 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: gina digioia ; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 16076399
• Report Number: 1118880-2022-00102
• Device Sequence Number: 12308782
• Product Code: DYB
• UDI-Device Identifier: 00389701011332
• UDI-Public: 00389701011332
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K173831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2022

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: 01/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 50-1060
• Device Lot Number: 0000236561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 12/30/2022
• Supplement Report FDA Received Date: 02/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2022
• 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: Other; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 84 KG