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

Catalog Number AB-05060-PK

Device Problem Entrapment of Device (1212)

Patient Problem No Information (3190)

Event Date 10/14/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device reportedly is unavailable for investigation at this time.The manufacturer will continue to monitor and trend related events.

Event Description

Reported event: on (b)(6) 2015, the patient underwent a left subtalar fusion, bma and autograft.The anesthesiologist utilized the stimucath continuous nerve block procedural kit for administration of medication for pain.Per the physician's instructions, once the medication had been administered from the pain pump, the patient's husband was to remove the catheter.The patient's husband describes the removal process as pulling 2-3 inches then noticing that there was a wire/string still implanted into the patient's thigh; he continued to pull the catheter another 4-6 inches then stopped out of concern that something went wrong.The husband called the doctor's office and was instructed to continue pulling the catheter firmly.As further attempts to pull the catheter as instructed, he noticed that the extension was coming out of the middle of the catheter.Once the wire/string was fully extended and the husband called the doctor's office again and was again instructed to continue to pull on the catheter firmly.After further unsuccessful attempts to remove the catheter, he took the patient to the emergency room.The emergency room physician unsuccessfully attempted removal of the catheter then ordered the patient be returned to the original hospital that implanted the catheter.On arrival the anesthesiologist unsuccessfully attempted to pull the catheter out.The catheter was surgically removed the next day.The patient's condition is unknown.

Manufacturer Narrative

(b)(4) no lot number was provided.A device history record review was based upon a lot number from sales history data.A device history record review was performed on the stimicath catheter with no relevant findings.The ifu for this kit, b-05060-101d; rev.03, 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.During catheter removal, if resistance is encountered, stop; reposition patient and attempt removal again.Pressure on skin in the opposite direction from direction catheter is being pulled often helps to facilitate 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.No lot number was provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the catheter with no evidence to suggest a manufacturing related cause.The potential other remarks: cause of catheter being difficult to remove could not be determined based upon the information provided and without a sample.Results - no result code available that could accurately describe that the complaint was confirmed, but the root cause is unknown.

Event Description

Reported event: on (b)(6) 2015, the patient underwent a left subtalar fusion, bma and autograft.The anesthesiologist utilized the stimucath continuous nerve block procedural kit for administration of medication for pain.Per the physician's instructions, once the medication had been administered from the pain pump, the patient's husband was to remove the catheter.The patient's husband describes the removal process as pulling 2-3 inches then noticing that there was a wire/string still implanted into the patient's thigh; he continued to pull the catheter another 4-6 inches then stopped out of concern that something went wrong.The husband called the doctor's office and was instructed to continue pulling the catheter firmly.As further attempts to pull the catheter as instructed, he noticed that the extension was coming out of the middle of the catheter.Once the wire/string was fully extended and the husband called the doctor's office again and was again instructed to continue to pull on the catheter firmly.After further unsuccessful attempts to remove the catheter, he took the patient to the emergency room.The emergency room physician unsuccessfully attempted removal of the catheter then ordered the patient be returned to the original hospital that implanted the catheter.On arrival the anesthesiologist unsuccessfully attempted to pull the catheter out.The catheter was surgically removed the next day.The patient's condition is unknown.

• Brand Name: 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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5667551
• MDR Text Key: 45574581
• Report Number: 1036844-2016-00256
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: AB-05060-PK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention