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

Model Number	N/A
Medical Device Problem Codes	Peeled/Delaminated (1454); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Terumo medical received an fda medwatch report number mw5147927.The event description states that "upon access to vessel (heart catheterization), wire (introducer sheath) was inserted in needle from kit.The wire would not advance.Upon attempted removal of wire, the wire was appeared sheared.Piece of wire noted under fluoro in right wrist.Device embedded in tissue or plaque.".
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Should the sample arrive, the complaint will be reopened.The complaint cannot be confirmed for guidewire separation because a sample was not returned for assessment.Without a sample, the exact root cause cannot be determined.The complaint mentions that there was difficult access.The likely root cause of the event is that difficult access caused increased tensional forces to be exerted on the guidewire or that the guidewire was backed up over the needle, causing it to shear.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).
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information to sections a1, a2, a3a, a4, a5, a6, and b5.
Event or Problem Description
Additional information was received on 27jun2024: a piece of wire was still left in the patient's tissue.It was unknown if there was any damage to the patient's vessel or tissue.The patient was stable.Minimal blood loss was reported (do not have a stated amount).The patient was transferred to another facility for percutaneous coronary intervention (pci).

• 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: 18402214
• Report Number: 1118880-2023-00457
• Device Sequence Number: 3968568
• Product Code: DYB
• UDI-Device Identifier: 00389701009926
• UDI-Public: 00389701009926
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2023

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: 09/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 15-1050
• Device Lot Number: 0000343904
• 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: 11/30/2023
• Supplement Date Received by Manufacturer: 02/09/2024; 06/27/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 03/04/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2023
• 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: Other
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American