MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER

Model Number IPN919609

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Reported issue: epidural catheter placed in patient with no incident.Upon removal, the catheter sheared in two and some of the epidural remained in patient.There were no complications and due to the patient's age no removal of the broken part was performed.

Manufacturer Narrative

(b)(4).The customer returned one snaplock assembly and one epidural catheter.The returned components were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the extrusion and coil wire at the distal end appears to be stretched.The coil wire extends approximately 10cm beyond the extrusion as the distal tip is missing.The proximal side of the catheter appears to be intact as no damage was observed.The catheter appears to have been used as biological material can be seen on the inner coils and adhesive on the outer extrusion.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter.The returned catheter extrusion measures approximately 84.0cm.This indicates at least 4.5cm of the extrusion is missing as the specification for the epidural catheter indicates that the proper extrusion length of an epidural catheter is 88.5-91.5cm.A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this product warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal." the reported complaint of the catheter separating during removal was confirmed based upon the sample received.The returned catheter showed signs of stretching at the distal end and the distal tip was missing.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 and the observed evidence of the extrusion and coils stretching at the distal end, unintentional user error caused or contributed to this event.

Event Description

Reported issue: epidural catheter placed in patient with no incident.Upon removal, the catheter sheared in two and some of the epidural remained in patient.There were no complications and due to the patient's age no removal of the broken part was performed.

• Brand Name: ARROW EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16620424
• MDR Text Key: 312217329
• Report Number: 1036844-2023-00025
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10801902189117
• UDI-Public: 10801902189117
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN919609
• Device Catalogue Number: AK-05502
• Device Lot Number: 13F22L0788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/08/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED
• Patient Age: 90 YR