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

Model Number	GS-R6ST1C15W
Medical Device Problem Codes	Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.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 the sheath got stuck when trying to remove and stretched out and got stuck in the patient.Patient had to be transferred to different hospital for vascular surgery to remove.Additional information was received on 09may2025: we performed peripheral angiography and intervention via the left radial artery.Spasm was encountered upon removal of the sheath.The doctor attempted to treat with nitro paste and injections of lidocaine and nitroglycerin, as well as intermittent blood pressure cuff inflation/deflation.The spasm persisted.The doctor did not dictate, and acute blood loss associated with the delay.
Event or Problem Description
On 30may2025, terumo medical received fda medwatch report # (b)(4).The event description stated: at completion of a peripheral angiography and intervention via the left radial sheath, the sheath was being removed per mifu [manufacturer's instructions for use] and the sheath started to separation.Sheath was not able to be successfully removed.The patient was urgently transferred to [redacted] for surgical removal.Manufacturer response for sheath, terumo r2p sheath 149 cm (per site reporter).Cath lab staff contacted the sales rep, [redacted] to inform him of the patient transfer and he could pick up sheath after surgical removal at [redacted].Yesterday, [redacted], risk manager called to confirm the sheath is now in sterile processing for [redacted] to pick up.I emailed [redacted] and per phone discussion, he will pick up sheath today for manufacturer investigation.Balloon angioplasty.What problem did the user have:device failed (e.G.Broke, couldn't get it to work or stopped working); therapies being used on the patient at the time of the event that may have caused or contributed to the event: no other therapies; preexisting characteristics that may have contributed to the event: diabetes; hypertension; coronary heart disease.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide the additional information in sections a1, a4, a5, a6, b5 and h10 and to provide the completed investigation results and medwatch received.One r2p sheath was returned to terumo medical corporation for assessment.The sample was subject to visual analysis.A metacross balloon and guidewire are inserted into the sheath and cannot be removed.The sheath is broken 82.9 cm from the sheath hub.The sheath is damaged from the hub to the breakage.One r2p sheath was returned for assessment.The sheath is broken near the sheath hub.The sheath is damaged from the hub to the breakage.The complaint can be confirmed for a sheath breakage.The exact root cause cannot be determined.The likely cause is the spasm was not alleviated before attempted removal of the sheath.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 risktable (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: 22115240
• Report Number: 1118880-2025-00068
• Device Sequence Number: 17186275
• Product Code: DYB
• UDI-Device Identifier: 00389701011561
• UDI-Public: (01)00389701011561(17)261101(10)0000598123
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: GS-R6ST1C15W
• Device Catalogue Number: GS-R6ST1C15W
• Device Lot Number: 0000598123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White