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

Model Number	RSR03
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/19/2025
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
Terumo medical corporation received the following reported information: the cath lab had a completely shredded destination, which was multi-fractured and broken into two pieces.After the femoral puncture, problems arose when pulling out the sheath, the destination came loose in parts, and the distal part was saved with the help of a balloon.All parts of the destination device could be collected.The intervention took longer; however, the patient did not suffer any damage, and there was no bleeding or hematoma.The puncture was closed with an angio-seal.
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 destination device was returned to terumo medical corporation for product evaluation.The returned sample included the sheath and shelfpack label.The returned sample was subjected to visual analysis.The valve subassembly on the sheath was noted to not be the correct valve subassembly and not from the terumo destination.The sheath was broken into 5 pieces with 3 pieces held together by coil.There were signs of clamping and other forms of damage along the sheath.It was found that the device was broken at multiple points along the sheath.The complaint can be confirmed for sheath breakage.The exact root cause cannot be determined.The likely cause is user pulled during resistance.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.A nonconformance (nc) was initiated for the risk level increase.

• 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: 23839245
• Report Number: 1118880-2025-00178
• Device Sequence Number: 18523278
• Product Code: DYB
• UDI-Device Identifier: 00389701006185
• UDI-Public: (01)00389701006185(17)270901(10)0001035021
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: RSR03
• Device Catalogue Number: RSR03
• Device Lot Number: 0001035021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• 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