MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. STIMUCATH SET: 20G CSTH, 18G X 8CM NDL; ANESTHESIA CONDUCTION KIT

Catalog Number AB-20608-S

Device Problems Kinked (1339); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is not expected to be returned for investigation.The manufacturer will continue to monitor and trend related events.

Event Description

The catheter kinked when trying to retract the catheter back into the needle which is causing replacement of a new needle and catheter combination.The patient's condition was reported as fine.

Manufacturer Narrative

Qn#(b)(4).A device history record review was performed on the stimulating needle and epidural catheter with no relevant findings.The ifu for this product, b-02060-106a rev.02, was reviewed as a part of this complaint investigation.The ifu warns the end user, "do not advance catheter more than 5 cm.Do not force catheter if resistance is encountered.Extreme care must be taken to never adjust position of needle while catheter tip is still advanced beyond tip of needle.If resistance is encountered when retracting catheter into needle, remove needle and catheter as a unit from patient and repeat procedure.Forcefully pulling back on catheter may result in catheter breakage." 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 stimulating needle and epidural catheter with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of difficulty advancing the catheter through the needle could not be determined based upon the information provided and without a sample.

Event Description

The catheter kinked when trying to retract the catheter back into the needle which is causing replacement of a new needle and catheter combination.The patient's condition was reported as fine.

• Brand Name: STIMUCATH SET: 20G CSTH, 18G X 8CM NDL
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5830569
• MDR Text Key: 50677999
• Report Number: 9680794-2016-00114
• 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: 07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• 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: AB-20608-S
• Device Lot Number: 14F15L0423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2015
• 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