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

Model Number A-EP-042

Device Problems Mechanical Problem (1384); Device Issue (2379)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2017, the account reported that they had a catheter that the stylet was not able to be pulled out of the device.The account reported they had experienced this issue in the past but provided no additional information.On (b)(6) 2017, the account returned three catheters, one of which was missing approximately 1.5cm of the outer fep coating from the catheter's distal end.The internal spring was left fully intact.Needle and patient info were not provided to epimed by the account.No info was provided to epimed regarding the location of the missing 1.5cm of the catheter coating.The batch history records were reviewed for the reported device lot; revealing no abnormalities within the lot.Epimed has contacted the account requesting additional information regarding the reported complaint.Once the account replies to epimed, an updated report will be provided.

Event Description

On (b)(6) 2017, the account reported that they had a catheter that the stylet was not able to be pulled out of the device.The account reported they had experienced this issue in the past but provided no additional information.On (b)(6) 2017, the account returned three catheters, one of which was missing approximately 1.5cm of the outer fep coating from the catheter's distal end.The internal spring was left fully intact.

Manufacturer Narrative

Since the filing the mdr (1316297-2017-0008) for epimed complaint (b)(4), the account has responded to epimed's request for more information.The account notified epimed that the catheter shear did not occur during the procedure and was not caused by the procedure.The catheter was placed and physician was unable to remove the stylet.The physician removed the catheter and the stylet as a unit and cut the distal coating off from the device to investigate what may have caused the stylet to be stuck inside the catheter.Because the catheter was returned to epimed without the stylet inserted into the device, epimed was unable to determine what may have caused the reported complaint.However, epimed suspects that the catheter and stylet may have become pinched by an internal structure after catheter positioning, causing the resistance to remove the stylet experienced by the reporting account.

• 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: 6957437
• MDR Text Key: 90419077
• Report Number: 1316297-2017-00008
• 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: other
• Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial,Followup

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: Physician
• Device Expiration Date: 11/30/2021
• Device Model Number: A-EP-042
• Device Catalogue Number: 156-2112
• Device Lot Number: 11127874
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/06/2017
• Initial Date FDA Received: 10/18/2017
• Supplement Dates Manufacturer Received: 10/06/2017
• Supplement Dates FDA Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2016
• 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