MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC STIMUCATH CONTINUOUS NERVE BLOCK SET; ANESTHESIA CONDUCT KIT

Model Number IPN040032

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

Patient Problem Foreign Body In Patient (2687)

Event Date 02/01/2022

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

One of my colleagues placed above type of nerve catheter in a patients at our (b)(6) orthopedic and arthritic center site.She was d/c with home with the nerve catheter as usual for patients enrolled in our home catheter program.When trying to remove the catheter herself (as per our practice), the catheter broke.The distal end was subsequently removed in er by our aps.This is an isolated incident and has never happened before at the in my knowledge in our practice but i do trust you would likely to be made aware of this incident.Additional information: the metal wire and attached coiled tip were removed with gentle traction by one of our anesthesiologists.

Manufacturer Narrative

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

Event Description

One of my colleagues placed above type of nerve catheter in a patients at our (b)(6) orthopedic and arthritic center site.She was d/c with home with the nerve catheter as usual for patients enrolled in our home catheter program.When trying to remove the catheter herself (as per our practice), the catheter broke.The distal end was subsequently removed in er by our aps.This is an isolated incident and has never happened before at the in my knowledge in our practice but i do trust you would likely to be made aware of this incident.Additional information: the metal wire and attached coiled tip were removed with gentle traction by one of our anesthesiologists.

Event Description

One of my colleagues placed above type of nerve catheter in a patients at our holland orthopedic and arthritic center site.She was d/c with home with the nerve catheter as usual for patients enrolled in our home catheter program.When trying to remove the catheter herself (as per our practice) - the catheter broke.The distal end was subsequently removed in er by our aps.This is an isolated incident and has never happened before at the in my knowledge in our practice but i do trust you would likely to be made aware of this incident.Additional information: the metal wire and attached coiled tip were removed with gentle traction by one of our anesthesiologists.

Manufacturer Narrative

(b)(4).A lot number was not 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 epidural catheter with no relevant findings.The customer reported the catheter was difficult to remove.The customer returned one piece of an epidural catheter.The returned sample was visually examined with and without magnification.Visual examination of the returned catheter piece revealed the distal end of the catheter was returned based on the markings at the distal end.Returned catheter piece reveals the coil wire is stretched at the likely most proximal end, the coil wire stretches approximately 15cm beyond the extrusion.The tip of the distal end is completely separated from the catheter.Approximately 11.2cm of the distal tip was also returned.Although, completely separated from the catheter, the weld and some of the ribbon was still intact.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter piece using a ruler (10171599).The returned catheter extrusion measures approximately 18.9cm.This indicates at least 39.6cm of the extrusion is missing as the specification for the epidural catheter indicates that the proper extrusion length of an epidural catheter is 58.5-59.3cm per graphic b-19608-001 rev.10.Specifications per graphic b-19608-001; rev.10 were reviewed as a part of this complaint investigation.The ifu for this kit, b-02060-106a ; rev.2, was reviewed as a part of this complaint investigation.The ifu warns the user, "do not alter the catheter or any other kit/set component during placement, use, or removal.Never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage." also, on page one (1) under the catheter removal advisory, the ifu advises the user "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." on page four (4) under catheter removal procedure, the ifu warns once again "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.After removal of catheter, inspect distal tip for continuity." a corrective action is not required at this time as the condition of the sample received indicates unintentional user error caused or contributed to this event.The reported complaint of epidural catheter being difficult to remove was confirmed based upon the sample received.The returned catheter piece was missing approximately 39.6cm of extrusion from the likely most proximal end of the catheter.The coil wire at the likely most distal end is stretched approximately 15cm beyond the extrusion.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.A lot number was not 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.Therefore, based upon the condition of the sample received the observed evidence of the coil wire stretching at the likely proximal end, unintentional user error caused or contributed to this event.No further action is required at this time.

• Brand Name: STIMUCATH CONTINUOUS NERVE BLOCK SET
• Type of Device: ANESTHESIA CONDUCT KIT
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 13586718
• MDR Text Key: 286066234
• Report Number: 3006425876-2022-00223
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 20801902033158
• UDI-Public: 20801902033158
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN040032
• Device Catalogue Number: AB-19608-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2022
• 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: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention