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

Model Number	RSR01
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3a: sex: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provide.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: rn nursing team lead - vascular surgery.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.During a peripheral angiogram intervention, a destination 6x45cm sheath snapped in half and unraveled in the patient while trying to remove the sheath and dilator from the patient.The vascular surgeon then needed to perform a cut down to remove the sheath.The blood loss was less than 250cc.No equipment or other devices were used with the destination device.Additional information was received on 17nov2025: the dilator did not snap in half.The sheath unraveled and broke apart.
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 6 french destination was returned for product evaluation.The returned sample included the sheath and dilator.The returned sample was subjected to visual analysis.The dilator was not fully inserted into the sheath.The sheath was broken 28.3cm from the sheath hub.The pieces were held together by the coil.There were signs of stretching and clamping on the returned sheath.The sheath was observed to be broken.The complaint can be confirmed based on the returned sample.The exact root cause cannot be determined.The likely root cause is the user experienced resistance during withdrawal.Review of the devic 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: 23728950
• Report Number: 1118880-2025-00171
• Device Sequence Number: 18558756
• Product Code: DYB
• UDI-Device Identifier: 00389701006161
• UDI-Public: (01)00389701006161(17)271101(10)0001107155
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: RSR01
• Device Catalogue Number: RSR01
• Device Lot Number: 0001107155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2025
• 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: Other; Required Intervention
• Patient Sex: Unknown