MAUDE Adverse Event Report: EPIMED VERSA-KATH

Model Number A-EP-042

Device Problems Entrapment of Device (1212); Use of Device Problem (1670); Device Damaged by Another Device (2915)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/08/2015

Event Type  malfunction  

Manufacturer Narrative

Per epimed's investigation, epimed believes that the catheter in question was damaged as a result of the physician's technique.The account reported that the (tuohy) needle remained in place during initial removal of the catheter in question.Resistance was experienced by the physician during catheter withdraw.Epimed determined that approximately 2.0cm of the catheter's outer (fep) coating sheared off within the patient during this time.Epimed warns against this practice within their versa-kath ifu (pi-048 rev.0), precaution #5 states, "during catheter removal if resistance is encountered, stop, reposition the patient to open the vertebral interspaces and attempt removal.If further difficulty is encountered, fluoroscopy or x-ray may be indicated prior to further catheter manipulation." also, epimed warns against leaving the needle in place during removal of the catheter within their ifu (pi-048), stating: "do not remove catheter while needle is in place.Spring guide catheter and epidural needle must be removed together as a unit to prevent potential catheter damage." regardless once resistance was felt, the physician took appropriate measures and removed the catheter and needle together as a unit.Epimed believes if the (pi-048) versa-kath's ifu was followed in combination with using the package suggested introducer needle, it may have prevented damage to the catheter.

Event Description

On (b)(6) 2015, the account was performing a caudal epidural steroid injection.While removing the needle and catheter as a unit, resistance was experienced.As the catheter came out the internal spring began to unravel.Once the catheter was removed, the account realized that the versa-kath sheared, leaving approximately 1cm of material within the patient.The entire catheter was removed, besides the 1cm piece of material.The patient is currently doing well.However, dr.Diaz-ramirez has contacted a neurosurgeon to discuss the possibility ot removing the remaining piece of catheter.

• Brand Name: EPIMED VERSA-KATH
• Type of Device: VERSA-KATH
• Manufacturer Contact: 141 sal landrio dr.; johnstown, NY 12095 ; 5187250209
• MDR Report Key: 5197267
• MDR Text Key: 30515859
• Report Number: 1316297-2015-00004
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 954584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Model Number: A-EP-042
• Device Catalogue Number: 156-2112
• Device Lot Number: 11127041
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/23/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention