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

Model Number A-EP-089

Device Problems Device Issue (2379); Device Damaged by Another Device (2915); Human Factors Issue (2948)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

On october 11, 2017, a complaint was received by epimed stating that they had two racz catheters that began to fray when the distal tip of the catheter was inserted into the needle.They also stated that the doctor was unable to advance (the catheter) because they immediately started to fray.On october 20, 2017, the devices arrived at epimed for examination.During this examination, it was observed that approximately 2.5cm of catheter fep outer coating were sheared off from both of the returned catheter's distal ends.The remaining portion of each returned catheter remained intact; i.E.None of the remaining sections of catheter coating were damaged and the catheter's internal spring and ball weld remained in place.On october 20, 2017, epimed informed the reporting account of the investigational findings.The account could not account for the missing pieces of catheter coating.Because of this, epimed recommended that the patient see a neurosurgeon to determine if the coating remained in the patient.On (b)(6) 2017, the account reported to epimed that the patient had undergone a ct scan and that a possible foreign body was discovered.On (b)(6) 2017, the reporting account provided epimed with the results summary of the ct scan.The summary read in part, "faint linear density was located within the most distal aspect of the spinal canal extending from the patient's s3-4 junction to the mid as 5 level".The report stated that the suspected foreign body that was located within the patient's epidural space measured approximately 3.2cm in cephalocaudal dimension and 1-2mm in diameter.No other information is available at this time regarding patient or procedure status.However, due to the nature of the reported event, epimed will follow up with the account for a period of three months to ensure patient safety.

Event Description

On (b)(6) 2017, a complaint was received by epimed stating that they had two racz catheters that began to fray when the distal tip of the catheter was inserted into the needle.They also stated that the doctor was unable to advance (the catheter) because they immediately started to fray.

• Brand Name: TUN-L-XL
• 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: 7046710
• MDR Text Key: 93439368
• Report Number: 1316297-2017-00009
• 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: distributor
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 11/10/2017

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: 05/31/2021
• Device Model Number: A-EP-089
• Device Catalogue Number: 155-2542
• Device Lot Number: 31428042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/20/2017
• Initial Date FDA Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2017
• 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