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U.S. Department of Health and Human Services

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

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EPIMED INTERNATIONAL, INC. BREVI-KATH; RACZ CATHETER Back to Search Results
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.
 
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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 Key4798374
MDR Text Key15840419
Report Number1316297-2015-00002
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
954584
Number of Events Reported1
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 Number155-2393
Device Catalogue Number155-2393
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/26/2015
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 Number1
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