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

Model Number	50-1050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided a3b: gender: n/a.A6: race: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: ic.The actual device has not 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 two access sites were created in the same radial artery.The first access site was small, and they were unsure if they were in the vessel.The second access site was in the same artery was created to verify.A 014 wire through and a 035 catheter balloon was used, they took pics of rt/lt.They pulled the first sheath, and then pulled second sheath retrieved with a balloon.Additional information was received on 26jun2024: the physician gained access with two sheaths in the same radial artery.This sheath was the second sheath placed, which sheared during the procedure.Additional information was received on 27jun2024: the procedure was completed using the sheath.The patient was stable.The sheath sheared inside the patient and a balloon was used to retrieve.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted, however an image as provided by the customer.The complaint can be confirmed for sheath separation based on the status of the device in the provided image.The exact root cause could not be determined.The complaint mentions that the procedure was completed with this sheath and that the separation was noticed/addressed afterwards.The likely root cause of the sheath separation is that the sheath experienced high tensional forces when being pulled out from the artery, causing it to tear.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 ; 4103927218
• MDR Report Key: 19780116
• Report Number: 1118880-2024-00107
• Device Sequence Number: 8154169
• Product Code: DYB
• UDI-Device Identifier: 00389701011363
• UDI-Public: (01)00389701011363(17)260601(10)0000471245
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 07/18/2024

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: 06/01/2026
• Device Model Number: 50-1050
• Device Catalogue Number: 50-1050
• Device Lot Number: 0000471245
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/07/2023
• 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: 014 WIRE; 035 CATHETER BALLOON
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic