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

Model Number	RSS702
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
Terumo medical received an fda medwatch report # (b)(4) the event description states: "the cordis had a crack just above where the medication was connected.This led to medication leakage, due to the low volume of the medication (1.8ml/hr) this led to the patient most likely not receiving the medication.During evaluation of where the leak was coming from it was noted that the line was full of air.High risk medication, treprostinil was running through this line.Stopping this medication abruptly could have severe adverse effects.The patient was also at high risk of an air embolism due to the line filling with air quickly.".

• 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: 25236322
• Report Number: 1118880-2026-00273
• Device Sequence Number: 10184148
• Product Code: DYB
• UDI-Device Identifier: 00389701007489
• UDI-Public: (01)00389701007489(17)271201(10)0001113455
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K954234
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: RSS702
• Device Catalogue Number: RSS702
• Device Lot Number: 0001113455
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 05/20/2026
• Supplement Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2025
• 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: Other
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 165 LB