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

Model Number	GS-R6ST1C75W
Medical Device Problem Codes	Break (1069); Stretched (1601)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the sheath was removed without the dilator during radial artery spasm.The sheath stretched and fractured.The patient had to go to surgery to repair.The type of procedure performed was a coronary procedure.The estimated blood loss was less then 250cc.Additional information was received on 01jul2025: it is unknown what size glidesheath slender (gss) was used to start, however, the decision was made to upsize to the destination slender sheath (dss).While attempting to advance diagnostic catheter, there were tight spots that were felt in the upper arm (brachial artery).This is when the decision was made to insert the destination slender sheath (dss).After procedure while removing the destination slender sheath (dss) with dilator in place, the patient began to cry out in mid-forearm (radial artery).When the sheath came out, the distal end was damaged with the coil wire protruding.The patient went to surgery.The doctor stated that the vessels were smaller than usual.Destination slender sheath (dss) in-servicing has been scheduled to make sure staff is aware of 2.3mm - 2.5mm minimum diameters for radial artery.The patient was stable post-surgical intervention and has since been discharged.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: tech supervisor.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.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section h3, and to provide the completed investigation results.One r2p sheath, dilator, and packaging were returned to terumo medical corporation for assessment.The sample was subjected to visual analysis.The sheath is stretched 46.2-58.8 cm from the sheath hub.The sheath tip is separated and was not returned with the sample.One r2p sheath, dilator, and packaging were returned for assessment.The sheath is stretched near the sheath hub.The sheath tip is separated and was not returned with the sample.The complaint can be confirmed for a sheath tip separation.The exact root cause cannot be determined.The likely cause is the user encountered resistance during withdraw.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.

• 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: 22605856
• Report Number: 1118880-2025-00114
• Device Sequence Number: 18542612
• Product Code: DYB
• UDI-Device Identifier: 00389701012360
• UDI-Public: (01)00389701012360(17)271101(10)0001078523
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/24/2025

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: 0001078523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2025
• 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: GLIDESHEATH SLENDER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown