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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.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.A review of the device history record of the product code/lot# combination was conducted with no findings.
Event or Problem Description
The user facility reported that the sheath was inserted into the patient's right radial artery.The sheath diaphragm tore when a catheter was inserted into the sheath.The patient condition and procedure outcome were not affected.The event occurred intra-operative.The patient was not injured, medical or surgical intervention was not required.Additional information was received on 23 jun 23: the procedure performed was a left heart catheterization.The device was exchanged, and another terumo glidesheath ss 6 french was used to complete the procedure successfully.The patient was stable on transfer from cath lab.
Additional Manufacturer Narrative
This report is being sent as follow-up #1 to update section h3, and to provide the completed investigation results.One 6 fr glidesheath sheath was returned for assessment.The sheath was visually examined.A portion of the tip of the sheath was chipped outwards.The sheath tip id was measured to be 0.079" [2.0 mm] and the specification is 1.98-2.13 mm.The complaint can be confirmed for sheath tip mechanical damage based on the state of the returned device.The exact root cause of this event could not be determined.The likely cause of the event was that the sheath was damaged in the process of preparing the sheath for use and the forces applied to the sheath during insertion caused it to noticeably tear.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
• 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: 17284958
• Report Number: 1118880-2023-00339
• Device Sequence Number: 6232556
• Product Code: DYB
• UDI-Device Identifier: 00389701011134
• UDI-Public: 00389701011134
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K152173
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2023

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: 08/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 20-1060
• Device Lot Number: 0000324878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 07/09/2023
• Supplement Report FDA Received Date: 08/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO 5 FR. TIGER AND STANDARD 260 .035 J WIRE.
• Patient Sex: Unknown