MAUDE Adverse Event Report: EPIMED INTERNATIONAL, INC. TUN-L-XL; RACZ CATHETER

Model Number 155-2540

Device Problems Physical Resistance (2578); Positioning Problem (3009)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/13/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, epimed's quality assurance department was notified of an event that had recently occurred involving an epimed tun-l-xl catheter, (catalog # 155-2540).The customer reported, "when removing the catheter, physician was feeling resistance.After removing the catheter, it did not have the fep tube of about 13 cm length from distal tip.It might be remaining in the patient's body." to date, according to epimed's knowledge of the situation, the patient has not undergone any further surgery to remove the fep coating that remains in situ within the patient.The account has been informed to notify epimed if they remove the fep coating remnant.

Manufacturer Narrative

Device evaluation: on (b)(6) 2015, the complaint was reviewed.At this point in time the device was not yet returned; however, the supplier provided pictures and a video of the catheter in question for epimed's review.On (b)(6)2015, the catheter in question arrived at epimed's facility for physical review.Epimed's quality assurance department examined the catheter and the corresponding (rx) needle.The rx needle did not show any signs of abuse, i.E.Being bent or etc.Next, the catheter was closely examined using 7x magnification.While inspecting the tun-l-xl catheter, it was confirmed that there was approximately 13.6 cm of the catheter's (fep) teflon outer coating unaccounted for.The angle at which the catheter was sheared (proximal to distal), indicates that the corresponding rx needle most likely remained inserted within the patient during catheter withdraw; epimed warns against this practice within their ifu pi-004.Also, while reviewing the catheter, a skive approximately 0.5 cm in length was observed on the catheter's pet inner coating.This skive occurred approximately 14.5 cm from the catheter's distal end and exposed the internal spring beneath; however, the catheter's spring remained fully intact.Epimed has confidence that if the ifu pi-004 rev.4 (spring guide epidural catheter product) was adhered to, damage to the catheter could have been prevented.

• Brand Name: TUN-L-XL
• Type of Device: RACZ CATHETER
• Manufacturer (Section D): EPIMED INTERNATIONAL, INC.; 141 sal landrio dr.; johnstown NY 12095
• Manufacturer Contact: 141 sal landrio dr.; johnstown, NY 12095 ; 5187250209
• MDR Report Key: 4798351
• MDR Text Key: 5880048
• Report Number: 1316297-2015-00001
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: 954584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2015

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: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: 155-2540
• Device Catalogue Number: 155-2540
• Device Lot Number: 11405868
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2015
• Initial Date FDA Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• 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