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

Model Number A-EP-042

Device Problems Device Issue (2379); Device Damaged by Another Device (2915); Device Handling Problem (3265)

Patient Problem No Information (3190)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2017, the account reported that the physician was doing a cervical esi with an epimed versa-kath and an 18g rx coude.When the physician attempted to retract the catheter he found that it started to unravel.He inspected the catheter and felt like he was able to get all of the metal (spring coil) out, but wanted epimed to examine the device to determine if any of the catheter's coating may have been sheared off.Upon return to epimed, the device was examined.It was determined that 3/16" of the catheters outer coating was missing from the device.The internal spring remained fully intact.It is suspected that the catheter coating may have snagged on scar tissue or an internal structure during the procedure, leading to the aforementioned issue.It is also possible that the catheter coating became caught on the heel of the needle's bevel/tip and subsequently sheared.Based on the findings of the investigation, epimed will follow-up with the account for a period of three months to ensure patient safety.As an act of good faith, epimed supplied the account with a replacement versa-kath catheter at no charge.

Event Description

The physician was doing a cervical esi with an epimed versa-kath and an 18g rx coude.When the physician attempted to retract the catheter he found that it started to unravel.He inspected the catheter and felt like he was able to get all of the metal (spring coil) out, but wanted epimed to examine the device to determine if any of the catheter's coating may have been sheared off.

• 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: 6908490
• MDR Text Key: 88251525
• Report Number: 1316297-2017-00007
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/29/2017

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: Physician
• Device Expiration Date: 03/31/2022
• Device Model Number: A-EP-042
• Device Catalogue Number: 156-2112
• Device Lot Number: 11128028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other