MAUDE Adverse Event Report: EPIMED INTERNATIONAL, INC. BREVI-KATH; RACZ CATHETER

Model Number 155-2393

Device Problems Use of Device Problem (1670); Positioning Problem (3009)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/07/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015, a cervical esi procedure (t1-t2) was being performed with a brevi-kath and rk needle.During removal, the catheter sheared leaving a portion of both the catheter's coating and spring (approximately 4 cm) housed within the patient.The product in question was discarded.

Manufacturer Narrative

On 05/01/2015, epimed's (b)(4) received an email from a patient who was involved in a procedure where a piece of the brevi-kath catheter had sheared off within her upon removal.The patient stated within her email to epimed that the remaining piece of catheter will have to be surgically removed.The patient was initially seeking a reimbursement for the sheared brevi-kath catheter.This request was considered unusual; therefore it was further investigated by epimed's qa manager.During the investigation epimed was informed by dr.(b)(6) (patient's physician) that the patient had been involved in a procedure he performed where approximately 4 cm of both the coating and the internally wound spring had sheared off and was left housed within the patient.Epimed has since reached out to the physician who performed the procedure seeking additional information.However, the physician does not feel comfortable answering the questions requested of him.The physician stated that he is awaiting direction and guidance from his administration on how to proceed.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: BREVI-KATH
• 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: 4798374
• MDR Text Key: 15840419
• Report Number: 1316297-2015-00002
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 954584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/15/2015

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 Model Number: 155-2393
• Device Catalogue Number: 155-2393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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