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

Model Number	N/A
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A5: ethnicity: not provided for animal use.A6: race: not provided for animal use.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.The actual device is not available for return.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 valve was leaking at the level of the "screw." procedure type was a visceral embolization.There is no direct claim that the reported device caused or contributed to a patient injury or the need for medical intervention.The estimated blood loss was less than 250cc's.Additional information was received on 05 jun 2024: the destination was utilized to finalize the procedure.Leakage was observed midway through the procedure.The patient remains stable.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide the completed investigation results and report that this reported event has been reassessed and deemed not reportable based on the investigation of the sample.The inspection of the returned sample found the device to be of normal product; therefore, it is not reportable.One 6fr destination sheath hub and side tube assembly were returned for assessment.The returned components were subject to visual analysis.No abnormalities were seen.The hub was attached to a conforming sheath and leak tested with a dilator and with nothing inserted.The hub and valve passed leak testing in both instances.The complaint cannot be confirmed for valve or hub leakage because the sample passed leak testing.The exact root cause of the leakage experienced by the user could not be determined.The likely root cause of the leak during the procedure is that the valve was not properly screwed onto the sheath.No failure mode was detected on the returned device.Review of device history record (dhr) showed there were no issues noted during 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 design failure mode and effects analysis (dfmea).

• Brand Name: DESTINATION RENAL GUIDING SHEATH
• 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: gina digioia ; 950 elkton blvd; elkton, MD 21921 ; 4103927218
• MDR Report Key: 19641172
• Report Number: 1118880-2024-00090
• Device Sequence Number: 8610432
• Product Code: DYB
• UDI-Device Identifier: 00389701006185
• UDI-Public: 00389701006185
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/30/2024

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: 08/01/2026
• Device Model Number: N/A
• Device Catalogue Number: RSR03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• 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
• Patient Sex: Unknown