MAUDE Adverse Event Report: COOK, INC. ONE-PART PERCUTANEOUS ENTRY NEEDLE; TROCAR

Device Problems Break (1069); Retraction Problem (1536); Unraveled Material (1664); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/18/2022

Event Type  Injury  

Event Description

While getting access for a cardiac catheterization, using a cook 21g access needle (reference number sdn-21-7.0, order number g01618), after obtaining femoral arterial blood return, i inserted a 0.021" nitinol wire that comes in the terumo pinnacle precision access system (order no/ref: 70-5160, lot no 0000057614).I appreciated resistance shortly after exiting the needle.I tried to retract the wire to reorient it, and it wouldn't come back.I removed the needle and the wire, but when the needle came out the wire was still in the patient, obviously unraveling.After contralateral arterial access demonstrated that the wire tip was not in the arterial system (such that i couldn't snare it and remove it), we elected to try to remove the wire through our access point.It unfortunately unraveled and broke, leaving about 1 inch length of the wire tip in the soft tissue of the right groin.

• Brand Name: ONE-PART PERCUTANEOUS ENTRY NEEDLE
• Type of Device: TROCAR
• Manufacturer (Section D): COOK, INC.
• MDR Report Key: 13600623
• MDR Text Key: 286348988
• Report Number: MW5107704
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/24/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR
• Patient Sex: Male
• Patient Weight: 123 KG