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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: requested, not available due to hippa.Age & date of birth: requested, not available due to hippa patient sex: requested, not available due to hippa weight: requested, not available due to hippa.Ethnicity: requested, not available due to hippa.Race: requested, not available due to hippa.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: rcis.A review of the device history record of the product code/lot number combination was conducted with no findings.The actual device has been received yet 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 slender device involved stopcock fell off the sheath at the end of the procedure.The physician immediately used a hemostat to stop bleeding from side arm as a replacement for the lost stopcock.The blood loss was minimal and not a concern to the physician.Tomer concerned the entire lot may not be safe and requested replacement of 2 total boxes.Patient was in fine condition.Procedure outcome was successfully.The event occurred intra-operative.The patient was not injured, medical or surgical intervention was not required.Additional information was received on (b)(6) 2023: procedure performed was a right radial cardiac cath.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to update section h3, and to provide the completed investigation results.One 6fr gss sheath was received for returned for product evaluation.The sheath was subject to visual analysis.No abnormalities were seen on the sheath.The 3wsc was not attached to the side tube.The edge of the side tube was closely examined.No glue residue was observed on the end of the side tube.The complaint can be confirmed for 3wsc separation based on the condition of the returned device.The likely cause is that the 3wsc was not glued to the side tube, so when some force was applied on the 3wsc it was able to detach from the side tube.Non-conformances (nc) was opened to address the missing adhesion between the side tube and 3wsc.

• 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: 16710345
• Report Number: 1118880-2023-00044
• Device Sequence Number: 7454272
• Product Code: DYB
• UDI-Device Identifier: 00389701011981
• UDI-Public: 00389701011981
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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): 04/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 60-1065
• Device Lot Number: 0000266424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2023
• Supplement Date Received by Manufacturer: 04/17/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown