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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: rcis.A review of the device history record of the product code and lot number combination was conducted with no findings.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
The user facility reported that during assembly of the involved ik precision sheath, the tip of the dilator fractured.It was never inside the patient.A second sheath was opened and used for the procedure.Procedure was lower extremity angiogram.The event occurred pre-treatment.The patient was not injured, medical or surgical intervention was not required.Patient was in stable condition.The procedure outcome was successful.The patient was not injured, medical or surgical intervention was not required.There were no other devices or equipment used with the reported product.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to update section h3, and to provide the completed investigation results.One precision device was returned for product evaluation.The returned sample included the dilator and the pouch.The sample was subjected to visual analysis.The dilator was found to be broken 12.2 cm from the hub.The tip piece was measured to be 3.7cm.There appeared to be a hollow metal rod in the dilator shaft.X-ray images were taken, and the metal rod was found to span the full length of the dilator shaft attached to the hub.The rod was from the point of the breakage to a few millimeters to the caulking pin.The complaint can be confirmed for dilator mechanical separation.The exact root cause cannot be determined.The likely root cause is the user mishandled the dilator during insertion through the sheath valve.The device history record (dhr) review determined that the device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the failure mode and effects analysis (fmea).

• 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: gina digioia ; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 16959976
• Report Number: 1118880-2023-00117
• Device Sequence Number: 5452212
• Product Code: DYB
• UDI-Device Identifier: 00389701010885
• UDI-Public: 00389701010885
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2023

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 Expiration Date: 12/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 70-5165
• Device Lot Number: 0000201504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2022
• 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 Sex: Unknown