MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX; ANESTHESIA CONDUCTION KIT

Model Number 45-0299 REV. 100

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Numbness (2415); Device Embedded In Tissue or Plaque (3165)

Event Date 03/27/2020

Event Type  malfunction  

Event Description

A middle-aged female presented in labor.She was scheduled for repeat cesarean section today but decided for trial of labor.She had history of chari malformation type i s/p decompression.She has had two epidurals before, including one after decompression.Other than some neck pain after the first epidural, the procedures were done without incident.The anesthesiology attempted to place a l3/4 epidural.On one attempt there was loss of resistance and started to thread the catheter.The anesthesiologist felt some resistance, so stopped.The patient reported a transient right side paresthesia, so decided to pull the catheter and reposition.The catheter was at 12 cm at the touhy needle hub.The anesthesiologist made one attempt at pulling the catheter and felt a sudden "snap".The catheter had broken off inside the patient.Removed the needle and inspected the skin.The coiled wire was still in the patient, so pulled on it until it was removed.After inspecting the epidural catheter, it was cleanly broken at approximately 4 cm.After this, the anesthesiologist placed a new epidural catheter (easily inserted) at l4/5.Slowly dosed this catheter until the patient had relief of her labor pains.They had a long discussion with the patient and her husband about the retained catheter.After this, informed the charge nurse, recorded the reference number of the epidural kit, and called neurosurgery.The anesthesiologist spoke with neurosurgery- who recommended leaving it in place and monitoring; thinks it is unlikely to require any treatment.Pt had a successful vaginal delivery at 4 am and was easily able to move lower extremities in the morning.The second catheter was easily removed.Pt had an mri done and was seen by neurosurgery who continued to recommend no further treatment was indicated at this time.Plan to follow up as outpatient.

• Brand Name: PORTEX
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 10100828
• MDR Text Key: 192669390
• Report Number: 10100828
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 45-0299 REV. 100
• Device Catalogue Number: A4134-17
• Device Lot Number: 3922278
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12045 DA