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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the involved glidesheath slender dilator sheered through the sheath.The event occurred intra-operative.Additional information was received on 18 jan 2023: no blood loss was reported.The patient was not injured during the event and medical or surgical intervention was not required.The patient was in stable condition.The procedure outcome was successful.Additional information was received on 24 jan 2023: they attempted to place in the bilateral iliac stents via radial artery.It was ultimately unsuccessful via the radial approach due to a subclavian stenosis but were successful in deploying it femoral.
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: tech tech.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.A review of the device history record of the product code/lot number combination was conducted with no findings.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to update section h3, and to provide the completed investigation results.One 7fr gss sheath with its dilator inserted and wire inserted were returned for assessment.The dilator was protruding through the side of the sheath, which was ripped open on one side and folded over.This hole was 3.5cm from the sheath tip.The wire exited from the top of the dilator, folded back, and pass through the rest of the sheath.The complaint can be confirmed for sheath mechanical separation.The likely root cause is that there was resistance to the advance of the dilator and wire due to the patient's subclavian stenosis, and that forcing the dilator and wire back in would have caused it to tear through the side of the sheath.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 and effects analysis (dfmea).

• 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: 16349635
• Report Number: 1118880-2023-00009
• Device Sequence Number: 6261119
• Product Code: DYB
• UDI-Device Identifier: 00389701012087
• UDI-Public: 00389701012087
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 80-1070
• Device Lot Number: 0000250575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 02/10/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GORE ILLIAC STENT GRAFTS.
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 78 KG