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

Model Number	54-74501
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: expiration date: unknown due to unknown lot number.D4: udi: unknown due to unknown lot number.E3: occupation: product specialist.H4: device manufacture date: unknown due to unknown lot number.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.The actual device has not 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 destination sheath broke off in the patient during the procedure and had to be snared out by the doctor.Access was via groin.There was no blood loss.The reported event did result in patient injury and/or require medical or surgical intervention.
Event or Problem Description
Additional information was received on 09jun2025: a peripheral angiogram was the type of procedure being performed for the patient.A pre-deployment angiogram was performed.There were no issues with insertion.There was no stenosis or plaque present in the access site.The patient was stable.Testing was performed to ensure the broken sheath was removed entirely.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information in sections a1-a6, d4: lot number, d4: expiration date, d4: udi, b5, and h4.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Since the sample was not available for evaluation, the complaint cannot be confirmed for sheath separation.The exact root cause cannot be determined.The detailed device history record (dhr) review determined that the device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the failure mode and effects analysis (fmea)/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: 22125571
• Report Number: 1118880-2025-00069
• Device Sequence Number: 15627638
• Product Code: DYB
• UDI-Device Identifier: 00389701008851
• UDI-Public: (01)00389701008851(17)270401(10)0000732136
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/02/2025

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: 54-74501
• Device Catalogue Number: 54-74501
• Device Lot Number: 0000732136
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: 06/09/2025; 07/11/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 07/07/2025; 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• 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: Other; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White