MAUDE Adverse Event Report: TELEFLEX MEDICAL RADIAL ARTERY CATHETERIZATION SET WITH INTEGRATED NEEDLE A-LINE KIT; CATHETER, PERCUTANEOUS

Model Number RA-04020-SP

Device Problems Material Separation (1562); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/12/2022

Event Type  Injury  

Event Description

During placement of an arterial line for hemodynamic monitoring approximately 1 cm fragment of arterial catheter appeared to separate from the remaining catheter and remain within the patient's left wrist.The left radial pulse was identified following induction of anesthesia, and the overlying skin was prepped widely with chlorhexidine.An arrow 20-gauge arterial catheter/22-gauge tw needle set was advanced using landmark and pulse technique toward the artery.Flash was noted within the arrow kit lumen, and the wire was advanced without resistance to its full depth.Resistance was encountered during subsequent gentle advancement of the catheter over the guide wire, prompting withdrawal of the catheter/needle set.The needle was removed without resistance.After removal, the distal end of the catheter was noted to be missing.Using ultrasound, the catheter fragment was identified adjacent to the radial artery.Normal pulsation of the artery was observed on ultrasound.The patient had normal capillary refill throughout the left hand with warm digits and a palpable radial pulse.There was no evidence of compromise to vascular integrity or distal perfusion.The patient required an additional surgical procedure to remove the catheter fragment.The fragment was noted to be within the adventitia of the radial artery.It was able to be removed in its entirety.

• Brand Name: RADIAL ARTERY CATHETERIZATION SET WITH INTEGRATED NEEDLE A-LINE KIT
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 16042374
• MDR Text Key: 306092717
• Report Number: MW5113933
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: RA-04020-SP
• Device Lot Number: 14F22G0319
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White