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

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 involved destination device was defective and is visibly slightly deformed and frayed at the tip of the sheath at the transition from the dilator.The doctor complained about the product material and that the sheath was too soft.Patient condition was not harmed.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide additional information to section a2, a3, b5 update section d9, h3, and to provide the completed investigation results.The actual device has been returned for evaluation.One 6 fr destination sheath with its dilator fully inserted was returned for evaluation.The tip of the sheath was visually assessed.It was deformed with the tip crinkled inwards and fraying at the tip edge.The complaint can be confirmed for deformation of the sheath tip based on the condition of returned device.The exact root cause could not be determined.Historically, deformations of the sheath tip occur during insertion, as the destination sheath tip is atraumatic and designed to prevent damage to the artery if faced with resistance.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).
Event or Problem Description
Additional information was received on 17 jan 2024: the procedure performed for the patient at the time the difficulty with destination occurred was percutaneous transluminal angioplasty (pta) crossover.Procedure sheath size used was a 6f.There were no difficulties with arterial access, sheath, guidewire, or catheter insertion.An angiogram was not performed.There was no reported blood loss.Patient condition is stable.No concomitant medical products were used with the involved device.

• 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 ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 18508753
• Report Number: 1118880-2023-00467
• Device Sequence Number: 7801978
• Product Code: DYB
• UDI-Device Identifier: 00389701006161
• UDI-Public: 00389701006161
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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: 02/01/2026
• Device Model Number: N/A
• Device Catalogue Number: RSR01
• Device Lot Number: 0000410535
• 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: 12/13/2023
• Supplement Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 05/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2023
• 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 Age: 76 YR
• Patient Sex: Male