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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that upon opening the packaging of the destination product, it was noticed that the grey tip of the destination has lifted off or is coming off from the sheath.The procedure was completed successfully.There was no impact of event on patient.Additional information was received on 18sep2023: the device was not used on the patient.The patient was stable.There was no known affect as a result of the event.Additional information was received on 19sept2023: it was confirmed that the product was not used on the patient and there is no known effect on the patient as it was discovered upon receipt/preparation.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: requested, unknown.A review of the device history record of the product code and lot number combination was conducted with no findings.One 6fr destination sheath with its dilator fully inserted was returned for evaluation.The tip of the sheath was visually assessed.Blood from the procedure was visible on the sheath.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 the 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 PERIPHERAL 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 ; 6402040886
• MDR Report Key: 17885900
• Report Number: 1118880-2023-00408
• Device Sequence Number: 6901332
• Product Code: DYB
• UDI-Device Identifier: 00389701008912
• UDI-Public: 00389701008912
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K172995
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2023

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: 12/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 54-54501
• Device Lot Number: 0000375073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• 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