MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT

Catalog Number SJ-05501

Device Problems Difficult to Remove (1528); Torn Material (3024)

Patient Problem No Information (3190)

Event Date 08/26/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is reportedly unavailable for return.The manufacturer will continue to monitor and trend related events.

Event Description

There was an attempt to remove the catheter from the patient.When resistance was met another clinician was brought in to assist, continual resistance was met and when the anesthesiologist attempted again, the catheter sheared.Approximately 7cm of intact catheter had to be surgically removed from the patient's epidural space.The patient's condition was reported as unknown.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this kit, e-17019-100d; rev.3, was reviewed as a part of this complaint investigation.The ifu warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal.During epidural catheter removal, the literature indicates a force of approximately 1/3 of a pound is all that is necessary to exert if patient is properly positioned in the recommended lateral neutral position.".

Event Description

There was an attempt to remove the catheter from the patient.When resistance was met another clinician was brought in to assist, continual resistance was met and when the anesthesiologist attempted again, the catheter sheared.Approximately 7cm of intact catheter had to be surgically removed from the patient's epidural space.The patient's condition was reported as unknown.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5945807
• MDR Text Key: 54546585
• Report Number: 1036844-2016-00485
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: SJ-05501
• Device Lot Number: 23F16B0040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention