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

Model Number A-EP-042

Device Problems Retraction Problem (1536); Device Damaged by Another Device (2915); Human Factors Issue (2948); Device Handling Problem (3265)

Patient Problem No Information (3190)

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

After decontamination, the 21g versa-kath catheter was examined.During examination, it was evident the catheter's fep outer coating and pet inner coating had sheared near the distal end.The internal spring remained intact, but was stretched and uncoiled.It was determined that approximately 12cm of the catheter coating was missing from the catheter's distal end.This coating fragment was not returned to epimed.It was reported by the account that the coating fragment was not retained outside of the patient by the physician.Next, the returned portion of catheter was examined under the ce-180 (ram optical 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.Based on the damage to the catheter, as well as the description of the event from the reporting account, epimed has concluded that the damage to the catheter was a result of misuse by the end-user.Epimed warns against drawing back on the catheter while the needle is still in place within their ifu pi-004 rev.3 (spring guide epidural catheter products) § warnings: do not remove catheter while needle is in place.Spring guide catheter and epidural needle must be removed together as a unit to prevent potential catheter damage.The batch history records for the catheter were reviewed, revealing that the lot passed tensile strength inspection with an average break strength of 5.37 lbs.This is above the specified required break strength of 3.37lbs according to ihr-425 (final inspection versa-kath).No other abnormalities were revealed within the lot.On march 23, 2017, epimed emailed (b)(6), informing them that the returned catheter was missing approximately 12cm of the fep and pet coating.The account replied stating that the patient would be having a ct scan and neuro later that week.On march 24, 2017, epimed called (b)(4) to see if it was possible to acquire the needle that had been used during the reported incident; however, the needle had been discarded by the account.On march 29, 2017, epimed's clinical sales consultant, (b)(4), reported to epimed on behalf of the account that the catheter fragment could not be located anywhere within the patient during review of the ct scan.In the (b)(4), the reporting account stated that the patient was healthy.The account also stated that the procedure was eventually completed successfully.Although the catheter fragment could not be located in the ct scan, it is suspected that the catheter fragment is retained within the patient.Due to the nature of the complaint, epimed will follow up with the account for a period of three months to ensure patient safety.

Event Description

Physician was performing a caudal injection with insertion of the catheter.Upon removal of the catheter, physician was unable to remove the catheter.He then forced it through the needle, shearing the catheter.

Manufacturer Narrative

On (b)(6) 2017, (b)(6), administrator at (b)(6), reported to epimed that there is no update on the patient status at this time.

• 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: 6490420
• MDR Text Key: 72802286
• Report Number: 1316297-2017-00002
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/13/2017

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: 11/01/2021
• 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
• Initial Date Manufacturer Received: 03/17/2017
• Initial Date FDA Received: 04/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/10/2017
• 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