MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. SPINAL ANES/EPIDURAL CATH KIT; ANESTHESIA CONDUCTION KIT

Catalog Number AK-05560

Device Problems Break (1069); Unraveled Material (1664)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The catheter was placed with no issue.During removal, it broke and unraveled at the 9cm mark and had to be surgically removed.The patient's condition was reported as fine.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter broke during removal.The customer returned one epidural catheter (reference attached files (b)(4)).The returned catheter was visually examined with and without magnification.Visual examination of the returned catheter revealed the distal end of the catheter shows signs of stretching of the extrusion and coils from the distal tip to approximately 10cm from the distal tip.However, both the distal and proximal ends appear to be intact.The catheter appears to have been used as biological material can be seen between the catheter coils and adhesive residue is present on the catheter body exterior.No other defects or anomalies were observed (reference files (b)(4)).A dimensional inspection was performed on the returned catheter using a ruler (c05158).The returned catheter extrusion measures approximately 92cm.The extrusion appears to be stretched at the distal end of the catheter.This is why the catheter is slightly outside of specification of 88.5-91.5 cm per graphic kz-05400-002 rev.08.No part of the other remarks: catheter appears to be missing.Specifications per graphic kz-05400-002 rev.8 were reviewed as a part of this complaint investigation.The ifu for this product, k-05560-101a rev.07, was also reviewed as a part of this complaint investigation.The ifu contains catheter removal instructions with a list of warnings including, "never tug or quickly pull on catheter during removal from patient to reduce risk of breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.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." the ifu also provides alternate catheter removal techniques if difficulty is encountered and indicates "since any epidural catheter can inadvertently be separated if excessive force is applied during removal , clinicians must be aware of the importance of proper removal technique." a corrective action is not required at this time as the condition of the sample received indicates there were no visual defects found that could have contributed to this event.The reported complaint of the epidural catheter breaking during removal could not be confirmed based upon the sample received.The returned catheter was slightly stretched at the distal end most likely due to removal.However, there were no signs of breakage as both the distal and proximal ends were intact.The ifu for this product warns the user not to apply additional tension if the catheter begins to stretch as there is a risk for separation.Therefore, based upon the condition of the sample received, there were no visual defects found that could have contributed to this event.Results - no result code available that could accurately describe that the complaint was confirmed, but the root cause is unknown.

Event Description

The catheter was placed with no issue.During removal, it broke and unraveled at the 9cm mark and had to be surgically removed.The patient's condition was reported as fine.

• Brand Name: SPINAL ANES/EPIDURAL CATH 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: 6024230
• MDR Text Key: 57270035
• Report Number: 1036844-2016-00519
• 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: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: AK-05560
• Device Lot Number: 23F16E0834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2016
• 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