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

Model Number	N/A
Medical Device Problem Codes	Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical received an fda medwatch report # mw5147754.The event description states: "while attempting to gain access to the right radial artery for a cardiac catheterization procedure the guidewire which is used for access became stuck and was unable to be removed.The removal of the microwire required a vascular surgeon to perform a cutdown during the procedure and removal of the wire.".
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: risk manager.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.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide additional information to sections a2, a3a, a4, a5, a6 and b5.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
Additional information was received on 04mar2024: according to the patients medical record there was no finding suggestive of tortuous anatomy.The microwire (guidewire) used to gain access to the right radial artery for the cardiac catheterization procedure was unable to be removed by the proceduralist.The patient's condition was stable following the procedure.The estimated blood loss was noted to be less then 250cc.The retained microwire was removed during a surgical procedure and is not available for evaluation.No further intervention required, aside from the described cut down performed to remove the wire.
Additional Manufacturer Narrative
This report is being sent as follow-up no.2 to provide the 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 guidewire withdrawal difficulty because the sample was not returned for assessment.The exact root cause 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
• 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 ; 4103927218
• MDR Report Key: 18509578
• Report Number: 1118880-2023-00465
• Device Sequence Number: 7901474
• Product Code: DYB
• UDI-Device Identifier: 00389701009926
• UDI-Public: 00389701009926
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2024

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: 12/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 15-1050
• Device Lot Number: 0000370444
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 03/04/2024; 05/16/2024
• Initial Report FDA Received Date: 01/13/2024
• Supplement Report FDA Received Date: 04/02/2024; 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 178 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White