MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. STIMUCATH SET: 19G CATH, 17G X 8CM NDL; ANESTHESIA CONDUCT KIT

Catalog Number AB-19608-S

Device Problems Obstruction of Flow (2423); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/12/2018

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 they could not inject and the catheter was removed.On visual examination the catheter was torn away from the wire.Another catheter was placed and the patient's pain control was successful.

Event Description

It was reported that they could not inject and the catheter was removed.On visual examination the catheter was torn away from the wire.Another catheter was placed and the patient's pain control was successful.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this kit, b-02060-106a; rev.2, 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.Forcefully pulling back on catheter may result in catheter breakage.Excessive force should never be applied to nerve block catheters.If resistance is encountered, the position of the patient should be re-evaluated and another attempt to remove the catheter should be made.Skin traction in the direction opposite of that applied to catheter may facilitate removal.If removal is difficult, it is recommended that an x-ray be taken and that a consultation with a specialist be considered." 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 epidural catheter with no evidence to indicate a manufacturing related issue.Therefore, the potential cause of the catheter separating could not be determined based upon the information provided and without the sample.

• Brand Name: STIMUCATH SET: 19G CATH, 17G X 8CM NDL
• Type of Device: ANESTHESIA CONDUCT KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7694165
• MDR Text Key: 114179147
• Report Number: 3006425876-2018-00427
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K030937
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: AB-19608-S
• Device Lot Number: 14F18A0468
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1