MAUDE Adverse Event Report: COVIDIEN LLC ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER; CATHETER UMBILICAL ARTERY

Device Problems Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/22/2016

Event Type  Injury  

Event Description

A 3.5 fr dual lumen catheter (umbilical vessel catheter (uvc)) was placed emergently in main operating room following delivery of a (b)(6) infant via emergency cesarian section.The flushed 3.5 fr double lumen catheter was advanced to 7cm without difficulty.The line flushed and drew back easily.A 3.0 silk suture was not available in the operating room at the time; however, #3.0 coated suture was available.The catheter was sutured in place at 7cm with the 3.0 coated suture.After transferring the infant to the nicu, an x-ray was taken for line placement showed the uvc needed to be adjusted back 1.5 cm.While the bedside nurse was pulling the uvc back to correct position, the catheter snapped at the 6cm mark.The nurse was unable to grab the proximal tip and the catheter sunk deeper into the umbilical stump.The 6cm of catheter remained in the umbilical vein and was not able to be retrieved.The patient was transferred to a specialty hospital for surgical removal of the catheter.The infant did remain stable during this time.Follow up was that the coated suture material may have become sticky making it more difficult to withdraw the catheter when removing approximately 1-1/2 hrs after insertion.The corrective plan of action is to assure that we include placement of silk tape with the catheter trays.

• Brand Name: ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER
• Type of Device: CATHETER UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield, MA 02048
• MDR Report Key: 5916940
• MDR Text Key: 53555982
• Report Number: 5916940
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2016,08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: THE SUPPLY HISTORY LISTS THE FOLLOWING SUTURE THAT
• Patient Outcome(s): Other; Required Intervention