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

Model Number	70-6160
Medical Device Problem Codes	Break (1069); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/27/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E3: occupation: cath lab 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 corporation received the following information: it was reported that interventional cardiologist was performing an unknown type of procedure.The wire included in the 6fr precision access kit unraveled and broke off in the patient.Vascular surgeon was notified and it was determined wire fragment was not in vessel and was too risky to intervene.The approximate size of the wire that broke off inside the patient is unknown.The wire broke off at the access site.The patient remained in stable condition.They stated that the wire felt different.The estimated blood loss was less than 250cc.The procedure taking place for the patient at the time of the event was a diagnostic heart catheterization.
Event or Problem Description
Terumo medical received an fda medwatch report # mw5185570.The event description states: "a 68-year-old male was in teh cath lab for a cardiac catheterization.While the interventional cardiologist was attempting to gain access to the patient's groin using a micropuncture wire, the wire was noted to curl.The provider pulled back on the wire and part of the wire broke off inside the patient.The wire was noted to likely be in the tissue and not the vessel.Vascular surgery was consulted for the retained wire, and no additional interventions are required at this time.".
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide the additional information in sections a2, a3a, a4, b5, e4, g2, g3, h10 and to provide the completed investigation results.One 6fr ik precision guidewire and packaging were returned to terumo medical corporation for assessment.The sample was subjected to visual analysis.The guidewire is uncoiling 40.9cm from the proximal end of the guidewire.The guidewire tip was not returned with the sample.The guidewire od measured 0.02065" on the portion that was not separated.The specification is < 0.021" , design requirements matrix (inputs, outputs, verification) - pinnacle precision access system.One 6fr ik precision guidewire and packaging were returned for assessment and the guidewire is separated.The complaint can be confirmed for guidewire separation.The exact root cause cannot be determined.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.A supplier action was initiated for this issue.

• 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 ; 9499890491
• MDR Report Key: 24723977
• Report Number: 1118880-2026-00075
• Device Sequence Number: 10140087
• Product Code: DYB
• UDI-Device Identifier: 00389701010786
• UDI-Public: (01)00389701010786(17)280101(10)0001124698
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 70-6160
• Device Catalogue Number: 70-6160
• Device Lot Number: 0001124698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/30/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2025
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 206 LB