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

Model Number 50-1060

Device Problems Break (1069); Entrapment of Device (1212); Unraveled Material (1664); Difficult to Advance (2920)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/11/2022

Event Type  malfunction  

Event Description

Doctor (dr.) 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 drs.Called for assistance.Dr.# 2 attempt to snare wire was unsuccessful.Patient added to dr.3 surgical schedule for surgical wire removal.No variance from typical workflow and or standard of care noted.Description of doctor #3 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 (dr.#3) was present for the entire case.

• Brand Name: GLIDESHEATH SLENDER
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 15893119
• MDR Text Key: 304601261
• Report Number: 15893119
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2022

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
• Device Model Number: 50-1060
• Device Catalogue Number: 50-1060
• Device Lot Number: 0000236561
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20805 DA
• Patient Sex: Male
• Patient Weight: 84 KG