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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the physician attempted to use the ik device involved in the patient's vein; however, the wire was not able to advance in past the needle, the wire kept knuckling.The physician attempted to back the wire out, and tip of the wire sheared off inside the patient.It was believed that the tip was inside the tissue tract, not the vein.The patient will have to have the wire surgically removed.The patient was in stable condition.The event occurred intra-operative.Additional information was received on (b)(6) 2022: the procedure performed when the tip of the wire broke was unknown.The wire tip was not removed from the patient.The tip is in the subcutaneous tissue.It was reported that the patient wasn't a candidate for surgery and eventually will have the wire removed later.
Additional Manufacturer Narrative
Reporter occupation - lead cardiovascular technologist.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.A review of the device history record of the product code/lot number combination was conducted with no findings.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.Terumo tmc performed a maude search on 30 nov 2022.Report number (b)(4) was found and was confirmed to be of the same reported event; therefore, the maude report has been provided.The actual device has not been returned; therefore, an evaluation of the actual device was unable to be conducted.When the device is returned the complaint will be reopened.The complaint cannot be confirmed since the device was not available for evaluation.The exact root cause cannot be determined.The likely root cause is the user pulled the guidewire back through the needle.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: 15631742
• Report Number: 1118880-2022-00080
• Device Sequence Number: 7941486
• Product Code: DYB
• UDI-Device Identifier: 00389701010786
• UDI-Public: 00389701010786
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2022

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: 11/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 70-6160
• Device Lot Number: 0000188990
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• 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: Other
• Patient Sex: Unknown