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

Model Number	RSB603
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A4: weight: 72.6kg.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: nurse manager cath lab.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: while closing the access site the tubing from the sheath detached unexpectedly.The estimated blood loss was less than 250cc.Additional information was received on 27oct2025: the left heart catheterization was completed successfully.The sheath was in place and the staff noticed that the tubing randomly disconnected without any application of force noted.They were able to exchange for an angio-seal 6fr sheath and close the arteriotomy with minimal blood loss and no patient harm.There were no additional supplies needed.
Event or Problem Description
Terumo medical received fda medwatch report # mw5178313 on 20nov2025.The event description states: "tubing from sheath came off.".
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide additional information in section b5 and provide the medwatch received, to update section h3, and to provide the completed investigation results.Based on the evaluation of the returned sample this report is now deemed not reportable.One 6fr ik sheath and packaging were returned to terumo medical corporation for assessment.The sample was subjected to visual analysis.The side tubing is separated at the sheath hub.No other damage or deformities were noted on the sheath.One 6fr ik sheath and packaging were returned for assessment and the side tube is separated from the sheath hub.The complaint can be confirmed for side tube separation.The exact root cause cannot be determined.Manufacturing was notified about this issue.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.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: 23605640
• Report Number: 1118880-2025-00170
• Device Sequence Number: 13241237
• Product Code: DYB
• UDI-Device Identifier: 00389701007595
• UDI-Public: (01)00389701007595(17)270601(10)0000756900
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RSB603
• Device Catalogue Number: RSB603
• Device Lot Number: 0000756900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2024
• 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: STANDARD CATHETERS
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Race: White