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

Model Number A-EP-042

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Retraction Problem (1536); Device Damaged by Another Device (2915); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/04/2016

Event Type  malfunction  

Manufacturer Narrative

On november 4, 2016, epimed received a call from (b)(6), reporting an incident involving a sheared versa-kath catheter.A 7cm fragment of the catheter was returned to epimed on november 9, 2016.The catheter fragment was closely examined under the ce-180 (ram optical measurement system).It appeared that the catheter had been cut by an external force; however, epimed determined this to be inconclusive based on the visual evidence alone.On november 11, 2016, epimed's qa analyst emailed susan ussery with additional questions regarding the initial reported complaint.According to the physician, while performing a cervical pain procedure, some resistance was experienced while inserting the catheter.He stated that he was using a caudal approach, and was attempting to position the catheter using the fluoroscope, but was experiencing difficulty.He stated that he attempted to withdraw the catheter, but met resistance.He withdrew the needle, and then the catheter, and that is when he noticed the defect.Although a patient was involved at the time of the reported incident, no adverse events or harm occurred during the procedure.The sheared catheter fragment was removed from the patient in its entirety, and the procedure was eventually completed successfully with a new catheter and a new rx coude needle.Epimed suspects that end-user error caused the shear to the versa-kath catheter.In response to epimed's questions regarding the reported complaint, the physician stated that he attempted to withdraw the catheter first, but met resistance.Epimed warns against this within their ifu pi-004 rev.3.Epimed believes if the ifu was followed, it may have prevented the damage to the catheter in question.Epimed also electronically reviewed 5 years of previous complaint history, but did not find any complaints involving a fully sheared versa-kath catheter.Epimed believes this was an isolated incident and a failure of the end-user to properly follow the device ifu.

Event Description

On november 4, 2016, epimed's quality assurance manager received a call from (b)(6), medical lab technician, at (b)(6), reporting that, "while the doctor was inserting the catheter, the catheter broke in half.The doctor was able to remove the piece of the catheter from the patient.".

• Brand Name: VERSA-KATH CATHETER
• Type of Device: VERSA-KATH 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 ; 5187250209
• MDR Report Key: 6151135
• MDR Text Key: 61707287
• Report Number: 1316297-2016-00020
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Medical Technologist
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 05/31/2020
• Device Model Number: A-EP-042
• Device Catalogue Number: 181-2112
• Device Lot Number: 31127262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2015
• 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 Age: 52 YR
• Patient Weight: 89