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

Model Number	RSR04
Medical Device Problem Codes	Break (1069); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E2: health professional: unknown.E3: occupation: materials management.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
Terumo medical corporation received the reported information.The renal sheath was used when a peripheral sheath should have been used.The sheath snagged a stent due to the lack of hydrophilic coating, and it also sheared upon removal.The patient was fine, and the procedure was successful.Ther procedure was a pad case.Additional information was received on 17oct2025: the product sheered and broke at the proximal end about an inch down from where the sheath and dilator connect.Nothing was left in the patient.All pieces were able to be retrieved.Blood loss was less than 250cc.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the complete investigation results.One 7fr destination guiding sheath was returned for product evaluation.The returned sample included the sheath.The sample was subjected to visual analysis.The sheath was observed to be separated approximate 1.5cm from the sheath hub.The sheath had signs of stretching and compression along the shaft.One 7fr destination guiding sheath was returned and was found to be separated.The complaint can be confirmed for sheath breakage.The exact root cause cannot be determined.The likely cause is the sheath caught unto a stent in the patient and broke.Review of the device history record (dhr) showed there were no issues noted during the manufacture of the product that could have contributed to this complaint condition.Currently no action is recommended since this risk evaluation is within the predetermined limits in the hazard based risk table (hbrt).

• Brand Name: DESTINATION
• 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: 23476944
• Report Number: 1118880-2025-00159
• Device Sequence Number: 18701483
• Product Code: DYB
• UDI-Device Identifier: 00389701006192
• UDI-Public: (01)00389701006192(17)270901(10)00001046424
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172995
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2025

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: RSR04
• Device Catalogue Number: RSR04
• Device Lot Number: 0001046424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2025
• 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
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Race: Black Or African American