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

Model Number	GS-R6ST1C12W
Medical Device Problem Codes	Break (1069); Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the physician called the terumo territory manager during the procedure, due to destination slender being stuck inside the patient's arm.The procedure being performed was lower extremity angio.The physician noticed initial resistance when using the glidecath pv multicurve, and again when initially trying to insert the destination slender.The tech also observed that the glidesheath slender was crimped down when removing it to do the sheath exchange.No ultrasound measurements were done on the radial artery prior to inserting destination slender.The terumo territory manager arrived mid procedure.The sheath had already started to unwind inside the arm when trying to retract it.The terumo territory manager discussed troubleshooting options to safely remove the sheath, including sedation, and potentially using blood pressure cuff technique.None of these options would safely get the sheath out, so vascular surgery needed to do a brachial cutdown to remove the sheath.The sheath was successfully removed at surgery.The terumo territory manager, who was present mid case, stated that the artery should have been measured with ultrasound prior to the procedure being performed, as it was likely far too small to accommodate a destination slender.The estimated blood loss was less than 250cc.Additional information was received on 30may2025: the patient was stable following the procedure.
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 is not available for return.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 provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed for a sheath breakage because a sample was not returned for assessment.Without a sample, the exact root cause cannot be determined.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: 22294722
• Report Number: 1118880-2025-00081
• Device Sequence Number: 8893133
• Product Code: DYB
• UDI-Device Identifier: 00389701011547
• UDI-Public: (01)00389701011547(17)270701(10)0000855606
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2025

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-R6ST1C12W
• Device Catalogue Number: GS-R6ST1C12W
• Device Lot Number: 0000855606
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/02/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown