MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW SPINAL ANES/EPIDURAL CATH KIT; ANESTHESIA CONDUCTION CATHETER

Catalog Number	AK-05560
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported "patient had an uneventful labor epidural placement.After delivery of the child, the labor epidural cathether was difficult to remove.Eventually, the catheter broke off and left about 2cm of the tip of the catheter.The patient was informed.A neurosurgeon was consulted.Ct scan showed 1.8cm epidural tip in the l3-4 epidural space.3 days later the patient had a laminectomy to remove the epidural catheter tip and all the fragments.Of note, the retained epidural catheter tip had a knot in it when it was removed." the patient's current condition is reported as "stable and discharged home".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer reported the catheter broke off during removal.The customer returned one snaplock assembly and one epidural catheter piece.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 piece revealed the proximal end of the catheter was returned and was intact.The returned catheter piece also reveals signs of stretching.The extrusion and coil wire are extremely stretched at the likely most distal end of the catheter 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 and adhesive material can be seen on the outer extrusion.No other defects or anomalies were observed.The customer also provided photos that appear to show a separated epidural catheter.A dimensional inspection was performed on the returned catheter piece.The returned catheter extrusion measures approximately 92.5cm.The extrusion and coil wire are extremely stretched at the distal end of the catheter.The measurement of what was returned falls beyond the specification of 88.5-91.5 cm per graphic, the returned catheter was not in specification based on the evidence of stretching of the extrusion/coil wire.A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this product 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 epidural catheter breaking off during removal was confirmed based upon the sample received.The returned catheter piece showed signs of stretching as the extrusion and coil wire were 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.
Event or Problem Description
It was reported "patient had an uneventful labor epidural placement.After delivery of the child, the labor epidural catheter was difficult to remove.Eventually, the catheter broke off and left about 2cm of the tip of the catheter.The patient was informed.A neurosurgeon was consulted.Ct scan showed 1.8cm epidural tip in the l3-4 epidural space.3 days later the patient had a laminectomy to remove the epidural catheter tip and all the fragments.Of note, the retained epidural catheter tip had a knot in it when it was removed." the patient's current condition is reported as "stable and discharged home".

• Brand Name: ARROW SPINAL ANES/EPIDURAL CATH 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20100463
• Report Number: 9680794-2024-00854
• Device Sequence Number: 7869458
• Product Code: BSO
• UDI-Device Identifier: 10801902005172
• UDI-Public: (01)10801902005172(11)240530(17)251231(10)33F24E0069(21)
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2024

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: 12/31/2025
• Device Catalogue Number: AK-05560
• Device Lot Number: 33F24E0069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2024
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown