MAUDE Adverse Event Report: Terumo Medical Corporation PINNACLE PRECISION ACCESS SYSTEM; INTRODUCER, CATHETER

Model Number	70-5130
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction

• Brand Name: PINNACLE PRECISION ACCESS SYSTEM
• 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 ; +1(949)989-0491
• MDR Report Key: 50780966
• Report Number: 1118880-2026-00655
• Device Sequence Number: 18626799
• Product Code: DYB
• UDI-Device Identifier: 00389701010472
• UDI-Public: (01)00389701010472(17)280901(10)0001598518
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K111606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: 70-5130
• Device Catalogue Number: 70-5130
• Device Lot Number: 0001598518
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2026
• 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
• Patient Sex: Unknown