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

Catalog Number	AK-05502
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It is reported that: "i began the epidural in the sitting position, followed sterile technique and had a first pass loss of resistance at the l3/4 level.Her ligament was firm and given her height i was not surprised to find the epidural space approximately 1-1.5cm from the hub of the needle.This would give a loss of resistance at a depth of approximately 7 cm.I threaded the catheter approx 4cm into the epidural space and while doing so the back of the catheter slid onto a non-sterile area.Given her stage in labor i elected to pull the catheter back through the tuohy and replace it.I pulled lightly and met slight resistance.My second pull was slightly more forced but still in the mild category and the catheter unwound quickly in front of me.The catheter did not pull out intact a few centimeters then unwind.It came apart quickly without pulling back intact at all.The wire of the epidural remained in the needle, and i was holding only a short piece of catheter.Given her depth to the epidural space from the skin and having already threaded the catheter into the epidural space, i was confident that several centimeters of catheter remained.I pulled the needle back slowly at this point, supporting tension off the wire.No wire or catheter could be seen at the puncture site once the needle was removed.I proceeded to redo the epidural a space or two higher with the separately packaged catheter.This occurred quickly and without incident.Neurosurgery was consulted and the patient had surgery the following am for removal of the retained cath tip.The neurosurgery note indicates that the catheter was approximately 2.5cm from the patient's skin.Given the depth of her epidural space (7cm) and my experience trying to replace the catheter (pulled apart immediately), the catheter came apart inside the needle barrel." an xray and ct scan were performed as a result of the incident.The patient had no symptoms at the time and had a follow up review 16 days after the event with no reported numbness, pain or weakness.The patient was reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer reported the catheter broke during removal.The customer returned one epidural catheter piece and lidstock.The returned sample was visually examined with and without magnification.Visual examination of the returned catheter piece revealed the proximal end of the catheter was returned and was intact.The returned catheter piece also reveals signs of stretching.The extrusion is slightly stretched, while the coil wire is extremely stretched at the likely most distal end of the catheter.The coil wire extends at least 13cm beyond the extrusion and is tangled as the distal tip is not intact and was not returned.The returned catheter appears used as biological material can be seen between the inner coils.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter using a ruler.The returned catheter extrusion measures approximately 81.5cm.This indicates at least 7.0cm 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 per graphic.A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this kit warns the end user, "never advance catheter more than 5 cm beyond the needle tip.Advancing catheter more than 5 cm increases the likelihood of catheter-related complications." the ifu also 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 epidural catheter breaking during removal was confirmed based upon the sample received.The returned catheter piece showed signs of stretching as the extrusion was slightly stretched, while the coil wire was extremely stretched at the likely most distal end.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 coil wire stretching at the distal end, unintentional user error caused or contributed to this event.No further action is required at this time.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19275613
• Report Number: 9680794-2024-00395
• Device Sequence Number: 20750385
• Product Code: BSO
• UDI-Device Identifier: 60801902005139
• UDI-Public: 60801902005139
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: AK-05502
• Device Lot Number: 33F23L0419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female