MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION R2P DESTINATION SLENDER; INTRODUCER, CATHETER

Model Number	GS-R6ST1C75W
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: cath lab 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.
Event or Problem Description
The user facility reported that a physician was performing a radial cardiac catheterization using a 75-centimeter destination slender sheath.The physician encountered resistance when advancing the sheath into the radial artery, which was suspected to be due to a radial artery spasm.The physician attempted to remove the sheath from the radial artery but was initially unable to do so.After multiple attempts, the sheath was eventually removed, but the distal tip of the sheath had separated and remained inside the patient.This necessitated surgery to remove the distal tip.A successful cut-down surgery was performed to remove the distal portion of the sheath.Additional information received on (b)(6) 2025: the patient was given fentanyl and midazolam at the time of the artery spasm.The procedure was completed as intended after a surgeon performed a cut-down of the radial artery.The patient's condition was stable after the intervention.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section h3 and provide the completed investigation results.One r2p sheath assembly was returned to for assessment.The sample was subject to visual analysis.The sheath is bent 43.0cm from the sheath hub.The sheath is broken 53.3cm from the sheath hub.The broken piece of sheath is 18.4cm long.The sheath tip was not returned with the sample.The complaint can be confirmed for a sheath breakage.The exact root cause cannot be determined.The likely cause is the patient spasm was not fully alleviated before attempting removal of the sheath.The chief medical officer and pace were notified about this sheath breakage.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with terumo medical corporation specifications and procedures and the device was released in a conforming state.Currently, no action is recommended since the risk evaluation is within the predetermined limits in the hazard based risk table (hbrt).

• Brand Name: R2P DESTINATION 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: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 21646904
• Report Number: 1118880-2025-00038
• Device Sequence Number: 15359717
• Product Code: DYB
• UDI-Device Identifier: 00389701012360
• UDI-Public: (01)00389701012360(17)261101(10)0000586462
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K193125
• 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): 03/19/2025

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 Model Number: GS-R6ST1C75W
• Device Catalogue Number: GS-R6ST1C75W
• Device Lot Number: 0000586462
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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: Required Intervention; Other
• Patient Age: 53 YR
• Patient Sex: Male