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

Model Number	50-1050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the glidesheath slender device was used in a right heart catheterization (rhc).The patient had brachial vein access with an angiocath iv cannula.The iv cannula was typically exchanged over the wire that comes in the glidesheath slender (gss) kit.Normal prep performed of sheath.It was noted that the doctor felt resistance upon advancing the wire through the iv cannula access.Several attempts were made to advance the wire, and the wire tip kept "balling up", while visualized under fluoro.During an attempt the doctor experienced this scenario repeat and upon removing the wire realized that a portion had broken off and was left in the brachial vein.Vascular surgery was consulted to remove the piece left behind.Additional information was received on 09sept2024: the estimated blood loss was less than 250cc.The patient was stable.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided due to hospital policy.A2: age & date of birth: requested, not provided due to hospital policy.A3a: sex: requested, not provided due to hospital policy.A3b: gender: requested, not provided due to hospital policy.A4: weight: requested, not provided due to hospital policy.A5: ethnicity: requested, not provided due to hospital policy.A6: race: requested, not provided due to hospital policy.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 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 separation because the sample was not returned for assessment.The exact root cause could not be determined.Historically, guidewire separations have occurred due to pulling the guidewire back through the needle or due to high tensional forces during withdrawal.The instruction for use (ifu) states: "caution: do not withdraw the guidewire through the needle, as shearing of the guidewire may result." review of the 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 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: 20360878
• Report Number: 1118880-2024-00149
• Device Sequence Number: 20635142
• Product Code: DYB
• UDI-Device Identifier: 00389701011363
• UDI-Public: (01)00389701011363(17)260701(10)0000493652
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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: 50-1050
• Device Catalogue Number: 50-1050
• Device Lot Number: 0000493652
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ANGIOCATH IV CATHETER SET
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown