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

Model Number	54-64501
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E3: occupation: tech 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: when the physician tried to remove the sheath, it ripped.Then they cut the sidearm part off and tried to slide a smaller dilator down to the tip of the sheath to get it out.It did not work, and the patient had to go to the hospital to have the sheath removed.Additional information was received on 09dec2025: the procedure for the patient at the time the reported issue occurred was a left angio.It appeared that there may have been calcification/tortuous anatomy at the time the destination device ripped at the tip as described when trying to remove the tip of the sheath.The patient did not experience spasm at the time the sheath ripped.The patient was transported to the hospital and had a vascular cut down.Patient condition was stable.
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 6fr destination kit was returned to terumo medical corporation for product evaluation.The returned sample included the sheath.Visual analysis was performed on the returned sample.The sheath was cut and only 3.7cm was returned.The cut appeared to be clean and done after the alleged breakage.The sheath shaft was observed to be deformed.One 6fr destination kit was returned to terumo medical corporation for product evaluation.The returned sample was observed to be deformed and cut.The complaint can be confirmed for sheath mechanical separation.The exact root cause cannot be determined.The likely cause is there was resistance from the calcium/plaque during withdrawal.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: 23901623
• Report Number: 1118880-2025-00184
• Device Sequence Number: 10116779
• Product Code: DYB
• UDI-Device Identifier: 00389701008837
• UDI-Public: (01)00389701008837(17)271101(10)0001101695
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2025

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: 54-64501
• Device Catalogue Number: 54-64501
• Device Lot Number: 0001101695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 12/27/2025
• Supplement Report FDA Received Date: 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2025
• 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 Sex: Unknown