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

Model Number	54-74501
Medical Device Problem Codes	Material Separation (1562); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that when finishing a leg angiogram, upon removal of the sheath, the device began to unravel, and the hub broke away from the body of the sheath.They were able to retrieve the remaining portion of the sheath and there was no blood loss.The patient left the lab in stable condition with no immediate complications.The patient did have multiple previous surgeries at the access site.There was no patient injury and/or require medical or surgical intervention.Additional information was received on 28jun2024: they were able to remove the sheath that broke away.The physician reported the previous surgeries at the access site, likely contributed to the issue after tortuous scar tissue was encountered at the access site upon removal of the sheath.No additional devices or equipment were used with the reported product.
Additional Manufacturer Narrative
E3: occupation: rt.A review of the device history record of the product code/lot number combination was conducted with no findings.The sample was not available for assessment.The complaint cannot be confirmed for sheath separation because the sample was not returned for assessment.The exact root cause cannot be determined.The likely root cause of the sheath separation is that the sheath experienced high tensional forces when being pulled out from the artery due to the patient's tortuous scar tissue, causing the sheath to tear.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 ; 4103927218
• MDR Report Key: 19827692
• Report Number: 1118880-2024-00112
• Device Sequence Number: 18295942
• Product Code: DYB
• UDI-Device Identifier: 00389701008851
• UDI-Public: (01)00389701008851(17)260101(10)0000393407
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/25/2024

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: 01/01/2026
• Device Model Number: 54-74501
• Device Catalogue Number: 54-74501
• Device Lot Number: 0000393407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/18/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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