MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CONTINUOUS NERVE BLOCK KIT; ANESTHESIA CONDUCTION KIT

Catalog Number AB-05060-PKS

Device Problem Difficult to Remove (1528)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It is unknown if the device sample is available for evalaution.

Event Description

The customer alleges that the patient had difficulty removing the catheter.The patient went to an alternate facility.The catheter was visualized under ultrasound.The brachial plexus was observed to move when the catheter removal was attempted and the patient reported paresthesia during the removal.A neurosurgeon was consulted and the catheter was surgically removed.The catheter with metal tip appeared to be frayed.

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record (dhr) review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of a blocked catheter could not be determined based upon the information provided and without a sample.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

The customer alleges that the patient had difficulty removing the catheter.The patient went to an alternate facility.The catheter was visualized under ultrasound.The brachial plexus was observed to move when the catheter removal was attempted and the patient reported paresthesia during the removal.A neurosurgeon was consulted and the catheter was surgically removed.The catheter with metal tip appeared to be frayed.

• Brand Name: ARROW CONTINUOUS NERVE BLOCK 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5303285
• MDR Text Key: 33663820
• Report Number: 1036844-2015-00582
• 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: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: AB-05060-PKS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention