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

Model Number	54-64501
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	02/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A3b: gender: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.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 patient developed a large hematoma in his right groin shortly after placing a 6f x 45 destination in the left groin.The femoral artery was first accessed using ultrasound and micro puncture.A 6f sheath was placed, and diagnostic images determined an intervention was needed.The short sheath was exchanged for a 6f destination.Soon after, the vascular surgeon recognized a significant hematoma.A contrast image was used to confirm the bleed.It was difficult to determine if it was coming from the access site or a nearby side branch.After holding manual pressure and reducing the hematoma, the vascular surgeon tried to proceed; however, the hematoma grew, and he decided to abort the procedure.Upon removing the destination, the technician noticed a slight deformity at the distal tip of the sheath.It is undetermined if it was like this upon entering the body.If so, it would not have been a smooth transition from the dilator to the sheath and could have contributed.Manual pressure was administered, and hemostasis was achieved.The reported event resulted in patient injury and/or required medical or surgical intervention.It was inconclusive as to what caused the hematoma, but it is plausible that the sheath may have contributed.The hematoma was controlled by manual pressure, and hemostasis was achieved.The event occurred intra-operatively.Additional information received on 20 feb 2025: the procedure performed for the patient, prior to using the destination, was a planned left leg intervention of the sfa.The blood loss was less than 250cc.The patient is stable.A glidewire advantage was used with the destination.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9 and section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.One 6fr destination was returned for product evaluation.The returned sample included sheath and dilator.The sheath was subject to visual analysis.The sheath tip was observed to be broken.The complaint can be confirmed for 'sheath tip broken' based on the state of the device.The exact root cause could not be determined.All destination kits undergo 100% inspection before shipping from terumo.The likely root cause is that the sheath tip experienced resistance during insertion or user/patient un-intentionally moves during procedure.Review of device history record (dhr) showed there were no issues noted during the manufacture of the product that could have contributed to this complaint condition.No ncs or capas were opened for this issue within the last 12 months.Currently, no action is recommended since the risk evaluation is within the predetermined limits in 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: 21580539
• Report Number: 1118880-2025-00034
• Device Sequence Number: 9467316
• Product Code: DYB
• UDI-Device Identifier: 00389701008837
• UDI-Public: (01)00389701008837(17)270201(10)0000664875
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2025

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: 54-64501
• Device Catalogue Number: 54-64501
• Device Lot Number: 0000664875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 03/30/2025
• Initial Report FDA Received Date: 03/12/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GLIDEWIRE ADVANTAGE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 43 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native