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

Model Number	N/A
Medical Device Problem Codes	Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E1: phone number: requested, unknown.E2: health professional: requested, unknown.E3: occupation: requested, unknown.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 resistance was felt when advancing the involved destination device into the patient.When they withdrew the product, it was found that the guiding sheath had a broken distal tip.The event occurred intra-operative.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide additional information to section b5, to provide the device return date in section d9, to update section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.One 8fr 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 11 jul 2023: procedure taking place when the issue occurred was a subclavian stent implantation.No damage was noted to the sheath prior to advancement into patient.The patient anatomy was not tortuous when advancing the destination sheath into patient.There was no injury incurred for the patient due to this event.The broken sheath issue resolved for the patient to continue the procedure as intended by replacing with another one.The patient condition was stable.There was no reported blood loss.

• 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 ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17284951
• Report Number: 1118880-2023-00338
• Device Sequence Number: 12318133
• Product Code: DYB
• UDI-Device Identifier: 00389701009452
• UDI-Public: 00389701009452
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2023

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: 11/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 54-89001
• Device Lot Number: 0000190446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 07/09/2023
• Supplement Report FDA Received Date: 09/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/07/2022
• 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: 61 YR
• Patient Sex: Male