MAUDE Adverse Event Report: EPIMED ECONO-KATH; E-KATH

Model Number A-EP-059

Device Problems Use of Device Problem (1670); Positioning Problem (3009)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/31/2015

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2015, epimed's sales representative, (b)(6), forwarded an email from dr.(b)(6).Within the email, dr.(b)(6) questioned the composition of the material of the e-kath catheter's outer coating and wanted to know the biocompatibility of the catheter's outer coating.Epimed's (b)(6) responded to dr.(b)(6) request for biocompatibility information.Dr.(b)(6)explained, approximately 6-8 of the catheter's outer coating was retained within the sacral canal of the patient after the procedure.A picture was provided of the sheared catheter in question, along with what appears to be tuohy needle.The size and description of the needle was not given.Epimed has a very minimal amount of information pertaining to this case.Epimed suspects that the needle, remained in place during repositioning and/or catheter withdraw, causing the catheter to shear.Epimed warns against this practice within their ifu pi-004, rev.3 (spring guide epidural catheter products).Epimed has requested additional information about the event, but has yet to hear from dr.(b)(6).

Event Description

The catheter was threaded through the introducer (tuohy needle) and placed in the sacral canal.Upon removing the epidural catheter,the physician noticed that the nylon coating had "frayed", leaving the 6-8cm of insulation retained within the sacral canal after the procedure.

• Brand Name: EPIMED ECONO-KATH
• Type of Device: E-KATH
• Manufacturer Contact: 141 sal landrio dr.; johnstown, NY 12095
• MDR Report Key: 5113706
• MDR Text Key: 27217602
• Report Number: 1316297-2015-00003
• 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
• Reporter Occupation: Physician
• Report Date: 09/14/2015

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 Expiration Date: 07/01/2017
• Device Model Number: A-EP-059
• Device Catalogue Number: 154-1912
• Device Lot Number: 11125939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/26/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention