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 Foreign Body In Patient (2687)

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

On december 6, 2016, epimed received a call from (b)(6), reporting an incident involving a sheared versa-kath catheter.The catheter was returned to epimed on december 9, 2016.During examination, it was evident the catheter's fep outer coating had sheared near the distal end.The pet inner coating and the internal catheter spring remained intact.However, the internal spring was stretched and uncoiled.The catheter's coating was sheared approximately 2.5" from the catheter's distal end.The piece of coating was not returned to epimed.The catheter was closely examined under the ce-180 (ram opitcal measurement system).During this examination, it was discovered that the direction of the coating shear was from the proximal end of the catheter tracking towards the catheter's distal end.This is indicative of an attempt to remove the catheter while the catheter was either still "lodged" within the patient and/or while the needle was still positioned within the patient; i.E.The catheter may have become caught on the needle's heel of the bevel/tip during catheter withdrawal.During the description of the event, dr.(b)(6) stated that the catheter had been "inserted into s1 (l5-s1 lumbosacral joint), snagged in scar tissue, and the internal spring became uncoiled." dr.(b)(6) stated he did not withdraw on the catheter while the needle was still in place.However, the manner in which the catheter's coating was sheared is indicative of the catheter's coating becoming cut while being retracted against a sharp external force.Dr.(b)(6) stated that he was confident that the catheter coating that had sheard off during the procedure (due to being snagged) and had been left inside the patient.Dr.(b)(6) stated he would notify the patient of the findings and continue to observe the patient for any adverse reactions related to the incident.Epimed suspects that the catheter became caught on the needle's heel of the bevel/tip, possibly during an attempt to reposition or inadvertent retraction by the physician.Epimed warns against this in their ifu pi-004 rev.3.Epimed believes if the ifu was followed, it may have prevented the damage to the catheter in question.

Event Description

On december 6, 2016, (b)(6) radiology technician, (b)(6), contacted epimed's quality assurance department on behalf of dr.(b)(6); reporting that during a procedure, the catheter was inserted into s1, snagged in scar tissue, and the internal spring became uncoiled.The procedure was eventually completed successfully.The account requested notification if any of the catheter material was determined missing during epimed's investigation.

• 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: 6230625
• MDR Text Key: 64133171
• Report Number: 1316297-2016-00021
• 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: 01/06/2016

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: 03/31/2021
• Device Model Number: A-EP-042
• Device Catalogue Number: 156-2112
• Device Lot Number: 11127443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2016
• Initial Date FDA Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2016
• 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