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

Model Number	RSB703
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E3: occupation: system director, supply chain operations the actual device has 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 corporation received the following reported information: the patient was scheduled to have an ablation procedure, a 7fr terumo sheath was inserted in right femoral vein however on removal for a standard exchange of the sheath it fractured in the patient.The large portion of sheath that was fractured in the patient was later removed that day by the doctor from vascular surgery, the sheath was placed in a sterile cup.The estimated blood loss was less than 250cc.Additional information was received on 12nov2025: there was tortuosity experienced when the sheath break occurred during removal.The patient was not in spasm when the break occurred.There was some resistance experienced during sheath removal from the patient.The intended ablation procedure was able to be completed for the patient on (b)(6) 2025.The patient condition was stable, however transferred to the intensive care unit (icu) and then to the operating room (or) to vascular surgery for a cut down procedure to retrieve retained portion of the sheath.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section h3, and to provide the completed investigation results.One 7fr ik sheath, dilator, and packaging were returned to terumo medical corporation for assessment.The sample was subjected to visual analysis.The dilator tip is deformed.The sheath is separated 2cm from the sheath hub.There are scratches along the sheath body.The sheath is kinked along the sheath body.One 7fr sheath, dilator, and packaging were returned for assessment and the sheath is separated.The dilator tip is also deformed.The complaint can be confirmed for a sheath breakage.The exact root cause cannot be determined.The likely cause is the sheath encountered resistance during removal.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with terumo medical corporation specifications and procedures and the device was released in a conforming state.Currently, no action is recommended since the risk evaluation is within the predetermined limits in the hazard based risk table (hbrt).

• Brand Name: PINNACLE
• 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 ; 9499890491
• MDR Report Key: 23619709
• Report Number: 1118880-2025-00168
• Device Sequence Number: 18404949
• Product Code: DYB
• UDI-Device Identifier: 00389701007601
• UDI-Public: (01)00389701007601(17)271201(10)0001114838
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K003424
• 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): 11/21/2025

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 Model Number: RSB703
• Device Catalogue Number: RSB703
• Device Lot Number: 0001114838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2025
• 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 Age: 88 YR
• Patient Sex: Male
• Patient Weight: 72 KG