MAUDE Adverse Event Report: EPIMED INTERNATIONAL, INC VERSA-KATH; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number 156-2112

Device Problem Material Separation (1562)

Patient Problems Vomiting (2144); Foreign Body In Patient (2687)

Event Date 09/18/2020

Event Type  malfunction  

Event Description

Infant male underwent surgery under general anesthesia.Anesthesiologist had placed a caudal epidural catheter for pain control on day of surgery.Per the physician, standard epidural removal - tegaderm removed from skin - in continuation of motion ¿ catheter was pulled smoothly out without any resistance.Completed the procedure 2 days later and patient was discharged.Patient presented to er with emesis approximately 2 weeks later.Imaging was obtained that was negative for obstruction but incidentally found a retained catheter fragment (10.4 cm) extending from the level of the t9-t1- level to the l5-s1 level.The decision was made by parents and providers to remove the retained epidural catheter fragment.Lumbar laminectomy with foreign body removal performed.Discharged without complications.

• Brand Name: VERSA-KATH
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): EPIMED INTERNATIONAL, INC; 141 sal landrio drive crossroads business park; johnstown NY 12095
• MDR Report Key: 11071867
• MDR Text Key: 223593624
• Report Number: 11071867
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2020,10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 156-2112
• 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: 12/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 DA
• Patient Weight: 6