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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record of the product code/lot number combination was conducted with no findings.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 or Problem Description
The user facility reported that they had a left pedal access case with a glidesheath slender.Atherectomy and percutaneous transluminal angioplasty (pta) of left at/pop performed.Upon removing the jade balloon, they noted the sheath broke below hub at the shaft.The entire sheath and balloon/guidewire removed, and manual pressure applied.They were unable to perform final angiogram.The patient was stable and has been discharged home.The procedure was completed successfully.The estimated blood loss was less than 250cc.
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 5fr glidesheath slender sheath (gss), guidewire, and one concomitant balloon was returned for product evaluation.No abnormalities were seen on the guidewire.The sheath was completely pulled out from the sheath hub.The concomitant balloon was inserted into the sheath and was kinked between the separated sheath hub and sheath and at the beginning of the balloon.The hub of the balloon was examined it was a 014 6.0mm x 240mm 150cm jade pta balloon.The complaint can be confirmed for sheath separation at the hub due to the state of the returned sample.The exact root cause could not be determined.The balloon used in this procedure was meant to be used with a 5fr sheath.The likely root cause of the sheath separation is that the balloon used was too large and became stuck in the sheath during withdrawal, causing the sheath the separate at the hub and the balloon to kink.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).

• 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: 16792730
• Report Number: 1118880-2023-00026
• Device Sequence Number: 14875964
• Product Code: DYB
• UDI-Device Identifier: 00389701011363
• UDI-Public: 00389701011363
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2023

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: 03/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 50-1050
• Device Lot Number: 0000257923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Supplement Date Received by Manufacturer: 04/27/2023
• Initial Report FDA Received Date: 04/22/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• 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: JADE BALLOON.; VIPERWIRE 014.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Weight: 64 KG
• Patient Ethnicity: Hispanic
• Patient Race: White