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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Vascular Dissection (3160)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: rtr cv lab manager.A review of the device history record of the product code/lot number combination was conducted with no findings.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.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 wire 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).
Event or Problem Description
The user facility reported that the ik precision device, wire would not pass through the sheath.The wire had to be retrieved from the artery.The patient was in stable condition.The event occurred intra-operative.Medical/surgical intervention was required.The procedure outcome was successful.Additional information 20p mar 2023: procedure performed was a left and right heart cath.When they were gaining access, the doctor attempted to feed the wire through the needle and the tip of the wire was knotted up, within the needle.The doctor attempted to remove the wire; however, it was stuck in the needle.A 10 french catheter was threaded over the wire to try and remove the trapped wire back through however that did not work either.When the doctor pulled the wire back, the tip of the wire broke off (at the very tip).The wire tip was retrieved after the skin was nicked from a surgeon.The surgeon was able to visualize the wire tip fragment within the vein, just under the skin.The surgeon was then able to remove the wire with hemostats without any harm to the patient.Terumo medical received an fda medwatch report # mw5115904.The event description states that it was unclear how the wire formed a knot on itself inside the body.However, it became entrapped within the tissue and could not be withdrawn.The physician tried several times to do so but could not be removed.It unwound and stretched itself very thin.The vascular surgeon attempted to remove the wire however it snapped breaking the wire, requiring a blunt dissection of the vessel to remove the knotted wire.

• 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: 16740808
• Report Number: 1118880-2023-00051
• Device Sequence Number: 6843260
• Product Code: DYB
• UDI-Device Identifier: 00389701010793
• UDI-Public: 00389701010793
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/14/2023

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: 03/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 70-6160
• Device Lot Number: 0000254936
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Initial Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2022
• 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: Required Intervention
• Patient Sex: Unknown