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

Catalog Number SJ-05501

Device Problems Coiled (1098); Material Frayed (1262)

Patient Problems Skin Irritation (2076); Swelling (2091)

Event Date 01/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the epidural catheter was used on a surgical patient in the thoracic spine. The catheter was removed with tip missing. Ct scan indicates catheter starts at spinal canal at t-11,t-12 and ends in the spinous process of t-10,t-11. Additional reported information indicates the patient had a total hip repair where the epidural catheter was placed per routine for overnight stay pain control. After removal the first morning post-op the catheter was noted to have a coiled and frayed end with no tip attached. The patient was discharged after the ct scan and the surgeon determined that no further action was required. The patient did not have any physical complaints at the time. It is reported that on (b)(6) 2018 the patient complained of pain and swelling at the epidural catheter insertion site. These new symptoms were reported to have started after hearing the information that she would not be able to have an mri below the neck with this indwelling catheter tip.

Manufacturer Narrative

Qn# (b)(4). A device history record review was performed on the epidural catheter with no relevant findings. The ifu for this kit, e-17019-109a; rev. 06, was reviewed as a part of this complaint investigation. The ifu warns the end user, "never advance the catheter more than 5 cm. Advancing the catheter more than 5 cm increases the likelihood of the catheter tip being placed into the anterolateral portion of the epidural space and increases the potential for the catheter knotting. " 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. A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample. Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed on the catheter with no evidence to suggest a manufacturing other remarks: related cause. Therefore, the potential cause of the catheter tip breaking could not be determined based upon the information provided and without a sample.

Event Description

It was reported that the epidural catheter was used on a surgical patient in the thoracic spine. The catheter was removed with tip missing. Ct scan indicates catheter starts at spinal canal at t-11,t-12 and ends in the spinous process of t-10,t-11. Additional reported information indicates the patient had a total hip repair where the epidural catheter was placed per routine for overnight stay pain control. After removal the first morning post-op the catheter was noted to have a coiled and frayed end with no tip attached. The patient was discharged after the ct scan and the surgeon determined that no further action was required. The patient did not have any physical complaints at the time. It is reported that on 2/14/2018 the patient complained of pain and swelling at the epidural catheter insertion site. These new symptoms were reported to have started after hearing the information that she would not be able to have an mri below the neck with this indwelling catheter tip.

• 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: 7306876
• MDR Text Key: 101573345
• Report Number: 1036844-2018-00079
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/30/2018
• Device Catalogue Number: SJ-05501
• Device Lot Number: 23F17K0200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage