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

Model Number	40-1060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	08/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that following device removal of the guidepost after percutaneous coronary intervention (pci), it was noted that the valve on the 6fr glidesheath was stuck open, resulting in arterial blood being observed at the end of the sheath where the valve is located.Manual pressure and a tr band were applied, and the hematoma was expressed.
Additional Manufacturer Narrative
A2: date of birth: requested, not provided.A3b: gender: n/a.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.The actual device is not available for return.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide medwatch attachment and completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed for fluid issues because a sample was not returned for assessment.Without a sample, the exact root cause cannot be determined.The likely root cause is off-center insertion of the dilator damaged the valve, leading to the blood leakage.The glidesheath ifu was reviewed, and it states: "caution: insert the dilator into the valve center of sheath.Forced dilator insertion missing the valve center may cause valve damage, resulting in blood leakage." review of device history record (dhr) showed there were no issues noted during the manufacture of the product that could have contributed to this complaint condition.Currently, no action is recommended since the risk evaluation is within the predetermined limits in the hazard based risk table (hbrt).

• 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: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 4103927218
• MDR Report Key: 20595800
• Report Number: 1118880-2024-00166
• Device Sequence Number: 8788037
• Product Code: DYB
• UDI-Device Identifier: 00389701011042
• UDI-Public: (01)00389701011042(17)261101(10)0000602627
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2024

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: 07/01/2026
• Device Model Number: 40-1060
• Device Catalogue Number: 40-1060
• Device Lot Number: 0000602627
• 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: 10/04/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 11/03/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2024
• 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: Other; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female