MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW EPIDURAL CATHETERIZATION KIT WITH FLEXTIP PLUS; ANESTHESIA CONDUCTION KIT

Catalog Number AK-05503

Device Problems Difficult to Remove (1528); Material Protrusion/Extrusion (2979); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/14/2019

Event Type  malfunction  

Event Description

Epidural catheter placed by anesthesiologist; he notes: "positioned sitting upright, approach midline, needle (# 17 gauge, placed via loss of resistance technique (saline), depth of epidural space: 7cm; catheter depth at skin: 10 cm; catheter inserted into epidural space:3 cm; insertion level: l2-3." about 6 hours later, the patient delivered her baby vaginally.Post delivery the nurse tried to remove the catheter and met resistance, so she stopped.She called the charge rn who repositioned the patient, then attempted to pull out the catheter, but also met resistance and stopped.The crna was called.He attempted and when he pulled the catheter, it snapped/broke.At that point, the anesthesiologist was notified.He could see a bit of the catheter poking out under the skin, so he numbed the area and attempted to grasp the end of it from under the skin.He was unable to retrieve the cath, and because of the tension, it coiled back into the back.Afterwards, the anesthesiologist noted that there was no obvious problem with the catheter, and no visible knots on ct.He indicated that perhaps he could have removed it with some positioning techniques.For this reason, i do not believe this retained broken epidural catheter was caused by a catheter defect; but i did want the fda and manufacturer to be aware of this.The following day, the patient went to surgery and had the 7.5 cm catheter piece removed from her back.It is available in our pathology department for inspection, but we will not be releasing it.

• Brand Name: ARROW EPIDURAL CATHETERIZATION KIT WITH FLEXTIP PLUS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 9473947
• MDR Text Key: 170913554
• Report Number: 9473947
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: AK-05503
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 11680 DA
• Patient Weight: 94