MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION GLIDESHEATH SLENDER; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: age & date of birth: requested, not provided.A3: patient sex: requested, not provided.A4: weight: requested, not provided.A5: ethnicity: requested, not provided.A6: race: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: purchasing coordinator.A review of the device history record of the product code/lot number combination was conducted with no findings.The actual device has 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 glidesheath kit, sheath was observed to be frayed and was deemed unuseable for the readial procedure.There was no adverse patient affect reported.The case was delayed for two (2) minutes due to opening a new access kit.The event occurred intra-operative.Medical or surgical intervention was not required.
Additional Manufacturer Narrative
This report is being sent as follow-up #1 to provide the completed investigation results.One 6 fr gs sheath with its dilator fully inserted were returned for evaluation.The tip of the sheath was visually assessed.It was deformed with fraying at the tip edge.The complaint is confirmed for mechanical damage of the sheath tip.The complaint mentions that the sheath tip was frayed upon opening, however the dilator was inserted into the sheath.As such, it cannot be determined if the sheath was damaged before use or due to use.The exact root cause of this event could not be determined.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: GLIDESHEATH SLENDER
• 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: 17196104
• Report Number: 1118880-2023-00324
• Device Sequence Number: 7413401
• Product Code: DYB
• UDI-Device Identifier: 00389701011134
• UDI-Public: 00389701011134
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173831
• 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): 06/24/2023

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: 07/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 20-1060
• Device Lot Number: 0000302950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/24/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/03/2023
• 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