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

Model Number A-EP-042

Device Problems Device Damaged by Another Device (2915); Human Factors Issue (2948); Device Handling Problem (3265)

Patient Problem No Information (3190)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

The actual device was unable to be evaluated.Gmc reported to epimed on april 14, 2017, that the device was discarded after the procedure.The hospital stated that the patient is doing well and has left the hospital.A follow-up email to gmc requesting an update on patient status has not yet been returned.

Event Description

According to the doctor, "he removed catheter from the body during cervical procedure, but he didn't remove together with guide needle.So, teflon coating was peeled off around 1.5 cm - 2 cm and he supposed that a piece of teflon coating will remain between c5, c6, and c7.And, the piece of teflon coating hasn't been removed from the body yet.Also, he said that the teflon coating is not showing up in x-ray/ct.".

Manufacturer Narrative

On june 1, 2017, epimed emailed the account for additional information.On june 6, 2017, the account reported to epimed that they had checked and determined that there was no additional information to report regarding the patient in question.

• Brand Name: VERSA-KATH
• Type of Device: CATHETER
• Manufacturer (Section D): EPIMED INTERNATIONAL INC.; 141 sal landrio drive; johnstown NY 12095
• Manufacturer (Section G): EPIMED INTERNATIONAL INC.; 141 sal landrio drive; johnstown NY 12095
• Manufacturer Contact: kris knapp ; 141 sal landrio drive; johnstown, NY 12095
• MDR Report Key: 6533600
• MDR Text Key: 74049723
• Report Number: 1316297-2017-00003
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K954584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 03/28/2017

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: No Information
• Device Model Number: A-EP-042
• Device Catalogue Number: 156-2112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 05/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/05/2017
• Was Device Evaluated by Manufacturer?: No
• 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): Other