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

Model Number	GS-R6ST1C12W
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/04/2025
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: interventional cardiologist.The actual device was not available; therefore, the actual device will not be 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 upon insertion of the 119cm destination slender, it was noticed that the entry was not smooth and felt some resistance.Nonetheless, the device reached where it needed to be.After the intervention was complete, the doctor inserted a.035 wire and dilator before removing the long sheath.At about the halfway point, the sheath broke in half and got stuck in the patient.Luckily, the breakage happened at the arteriotomy site, therefore, they were able to put back the wire and dilator to get it to come out.The administration of vasodilators seemed to help as well.A vascband was applied and the patient rolled out of the room with no issue.The doctor believed it could have been due to spasm at the access site; however, they wanted a thorough investigation into the matter anyways.The procedure performed was a radial to peripheral right superficial femoral artery (sfa) intervention.The blood loss was less than 250cc.There was no surgical intervention required.
Additional Manufacturer Narrative
The actual device was not available; therefore, the actual device will not be returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.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: 21697083
• Report Number: 1118880-2025-00047
• Device Sequence Number: 12928576
• Product Code: DYB
• UDI-Device Identifier: 00389701011547
• UDI-Public: (01)00389701011547(17)270101(10)0000676559
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 03/26/2025

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: 0000676559
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 03/26/2025
• Supplement Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: .035 ZIPWIRE.; 5 FR MERIT PRELUDE INTRODUCER SHEATH.; METACROSS BALLOON.; MISAGO STENT.; MULTIPURPOSE GLIDECATH.; VASCBAND.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White