MAUDE Adverse Event Report: EPIMED INTERNATIONAL INC. CATHETER; VERSA-KATH

Catalog Number 156-2112

Device Problems Improper or Incorrect Procedure or Method (2017); Device Damaged by Another Device (2915); Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/18/2020

Event Type  malfunction  

Event Description

The patient had general anesthesia for surgical procedure on (b)(6) 2020.While the patient was under anesthesia, a caudal epidural was placed for pain management post-op.The patient had the epidural removed on (b)(6) 2020.At the time of the removal, the provider removing the catheter thought the entire catheter was removed.The patient returned to the emergency department for emesis and it was discovered through x-ray that 10.4cm of the epidural catheter was retained inside the patient epidural space.The decision was made by the parents and providers to surgically remove the retained epidural.The patient had a right l4-l5 hemilaminectomy to remove the epidural foreign body.At the time of the event, the patient had no prior significant medical history.The patient is recovering from both surgeries at this time, and is recovering per standard expectations.

• Brand Name: CATHETER
• Type of Device: VERSA-KATH
• Manufacturer (Section D): EPIMED INTERNATIONAL INC.; 141 sal landrio drive; crossroads business park; johnstown NY 12095
• Manufacturer (Section G): EPIMED INTERNATIONAL INC.; 141 sal landrio drive; crossroads business park; johnstown NY 12095
• Manufacturer Contact: 141 sal landrio drive; crossroads business park; johnstown, NY 12095
• MDR Report Key: 10930059
• MDR Text Key: 219357956
• Report Number: 1316297-2020-00002
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 156-2112
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 8 MO
• Patient Weight: 6