MAUDE Adverse Event Report: COOK INCORPORATED MICROPUNCTURE; INTRODUCER, CATHETER

Model Number G47944

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528); Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problems Unspecified Infection (1930); Device Embedded In Tissue or Plaque (3165)

Event Date 04/11/2021

Event Type  Injury  

Event Description

Elderly male was admitted to the icu with prevertebral infection with cord compression and positive blood cultures.A central line was planned.The plan was to use a micropuncture introducer kit, which utilizes a smaller needle and guide wire to gain access into the vessel.The patient¿s platelets were 12 and the plan was to reduce the puncture size and risk of bleeding.With ultrasound guidance, the right internal jugular was accessed with the 21 g needle with good venous blood flow.The guide wire was advanced through the needle into the vein and then met resistance at several centimeters in depth.The intern attempted to pull the guide wire back, but there was resistance.The needle was removed but the wire was unable to be retracted.Vascular surgery was consulted, and it was recommended to pull harder to remove the guide wire.The attending pulled the wire with some force and the guidewire came out.Ultrasound showed that the guidewire had broken and part of it was retained in the patient, within the lumen of the vessel.Vascular surgery was consulted again, with the plan to take the patient to the or for exploration and removal after platelet infusion.In the or there was a microwire which was lodged in the subcutaneous tissue and extending into the limb of the internal jugular vein, confirmed with bedside ultrasound.The surgeon dissected down to the vessel, the wire was then exposed, grasped and removed intact, and discarded.Nine days later, a ct angiogram of the chest revealed a retained wire (23 mm) in the neck, approximately 1.6 cm deep into the skin.It is assumed that the guidewire stretched and broke upon the first removal attempt by the attending.It is assumed the guidewire stretched and broke further upon the second removal attempt by the vascular surgeon contributing to the retained wire portion discovered nine days later.

• Brand Name: MICROPUNCTURE
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 12031605
• MDR Text Key: 257160205
• Report Number: 12031605
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/04/2021

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
• Device Operator: Health Professional
• Device Model Number: G47944
• Device Catalogue Number: MPIS-401-NT-U-SST
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 25185 DA