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

Model Number	54-74501
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: inventory manager.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 upon opening the destination sheath, the tech went to tighten the valve.The valve would not stay tight and appeared to unscrew itself.After many attempts, another device was opened, and the tech experienced the same issue.The tech applied dermabond to the valve thread and continued on with the case.The second destination was discarded.There was no blood loss.The procedure was an angiography.There was no patient injury and/or require medical or surgical intervention required.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.One 7 french destination was returned for product evaluation.The returned sample included the sheath, dilator, and shelf pack.The sample was subjected to visual analysis.The dilator was fully mated with the sheath.The valve connected to the valve and tightened.Functional testing was tightened.The valve was loosened and retightened.The valve luer connection would not stay tightened after the first attempt.It was loose with about a quarter turn.However, after subsequent attempts, it stayed tightened.The threads were observed, and no damage was found on them.The complaint can be confirmed for valve assembly difficulty issues.The exact root cause cannot be determined.The valve was found to tighten intermittently.Because of the dermabond applied to the device, it cannot be confirmed whether the intermittent tightening is a result of the dermabond or the device alone.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.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).

• 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: 20819772
• Report Number: 1118880-2024-00187
• Device Sequence Number: 18105479
• Product Code: DYB
• UDI-Device Identifier: 00389701008851
• UDI-Public: (01)00389701008851(17)260501(10)0000461212
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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 Expiration Date: 05/01/2026
• Device Model Number: 54-74501
• Device Catalogue Number: 54-74501
• Device Lot Number: 0000461212
• 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: 11/07/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2023
• 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