MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) THERACATH; ANESTHESIA CONDUCTION KIT

Catalog Number EC-055000

Device Problems Failure to Advance (2524); Extrusion (2934)

Patient Problem Tissue Damage (2104)

Event Date 08/23/2014

Event Type  malfunction  

Event Description

This event occurred during attempts to place an epidural catheter in labor & delivery.The epidural space was identified at l4/5 with easy loss of resistance, but the arrow brand epidural catheter would not thread.Note from anesthesia md: catheters not threading into the epidural space is an occasional occurrence during epidural placement and common trouble shooting procedures were attempted.Epidural space was re-identified by loss of resistance in the same interspace, but catheter again would not thread.Placement was reattempted at the l3/4 interspace where epidural space was identified by easy loss of resistance but catheter would not thread.The touhy epidural needle was advanced approximately 1mm further, and an unintentional dural puncture was encountered.A new arrow brand epidural kit was opened, and another attempt was made at the l2/l3 interspace.Epidural space was identified by loss of resistance, and catheter was placed easily.This epidural catheter provided very good pain relief for patient's vaginal delivery.After confirming patient was stable, and with good pain relief.I located the touhy epidural needle from the 1st epidural kit, and opened a new arrow epidural catheter.I was unable to pass a catheter through this epidural needle because what appears to be a not visibly identifiable defect in the end of the arrow touhy needle.The patient developed a slight post dural puncture headache on 8/24 and was treated conservatively with oral analgesia pain medication.The headache was still present, but improved to the point where patient felt comfortable being discharged home 8/25.Patient was informed of the problem with the touhy needle.Patient was informed that the ob anesthesia team would continue to follow up with her by telephone, and she was informed on the various ways of treating a post-dural puncture headache if it was to get worse, including the option of an epidural blood patch.Manufacturer response for epidural catheter, epidural catheter (per site reporter): materials management contacted the company representative.

• Brand Name: THERACATH
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.); 2400 bernville rd.; reading PA 19605
• MDR Report Key: 4088730
• MDR Text Key: 4745580
• Report Number: 4088730
• Device Sequence Number: 1
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 08/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: EC-055000
• Device Lot Number: 23F14B 0278
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2014
• Patient Sequence Number: 1
• Treatment: NO - ONLY THE ARROW KIT
• Patient Age: 31 YR
• Patient Weight: 114