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

Model Number	GS-R6ST1C12W
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during an endo vascular treatment (evt) procedure using the r2p destination sl guiding sheath via radial approach, blood leakage was observed 2-3 cm from the hub after placement.Upon inspection, a kink in the sheath was identified at the leakage site.Approximately 20 cc of blood was lost, which was considered minor.Consequently, the use of the guiding sheath was discontinued, and the procedure was switched to a femoral approach due to the case's severity, not the sheath issue.The procedure was successfully completed without any patient injury or need for medical or surgical intervention.The physician has requested verification of the leakage cause.The event was not due to a problem with the guiding sheath, but the physician seeks to understand the cause of the leakage.No equipment or other devices were used with the above product.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.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.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9, section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.One r2p sheath without a sheath hub was returned to terumo medical corporation for assessment.The sample was subject to visual analysis.The sheath is cracked 2.0cm from the sheath hub.The sheath is kinked 4.8 and 5.4cm from the sheath hub.The complaint can be confirmed for sheath damage.The exact root cause cannot be determined.The likely root cause is the sheath was kinked during use and led to the blood leakage the user experienced.The device history record was reviewed to ensure 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: 20754997
• Report Number: 1118880-2024-00174
• Device Sequence Number: 9303018
• Product Code: DYB
• UDI-Device Identifier: 00389701011547
• UDI-Public: (01)00389701011547(17)261101(10)0000586484
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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 Model Number: GS-R6ST1C12W
• Device Catalogue Number: GS-R6ST1C12W
• Device Lot Number: 0000586494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 01/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• 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
• Patient Sex: Unknown