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

Catalog Number	SJ-05501
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "we had an epidural catheter that broke off in a patient back during removal that i was able to still retrieve later on that morning." additional information received reports "after several hours an attempt was made with clamp to remove with gentle traction and it was successful.There was no issues relating to the patient.The residual catheter was removed with no patient harm." the patient's current condition is reported as "discharged home".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer reported the epidural catheter broke during removal.The customer returned one 10ml injection syringe, one catheter adapter, and two epidural catheter pieces.The components were received connected together.The returned components were visually examined with and without magnification.Visual exanimation of the returned syringe and catheter adapter revealed both components appear typical with no observed defects or anomalies.Visual examination of the returned catheter pieces revealed on the likely most proximal piece, the extrusion and coil wire are damaged/stretched at the likely distal end.The extrusion and coil wire on the likely most distal piece are also stretched at the point of separation at the likely proximal end with the coil wire extending approximately 9.5cm beyond the extrusion.Also, both the proximal and distal ends of the returned catheter pieces appear to be intact.The catheter appears to have been used as biological material can be seen between the inner coils and adhesive 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 catheter and lidstock.A dimensional inspection was performed on the catheter.The proximal end catheter extrusion piece measures approximately 78.0cm.The distal end catheter piece measures approximately 14.9cm.Both catheter pieces combine to measure approximately 92.9cm.None of the catheter appears to be missing.However, with the coils and extrusion being stretched, this is why the catheter is outside of the specification of 88.5-91.5 cm per graphic.A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this kit 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 during removal was confirmed based upon the sample received.The customer returned two catheter pieces that were separated at the extrusion.None of the catheter appeared to be missing.At the point of separation, the extrusion and coil wire were stretched on the likely proximal piece and was also stretched on the likely distal piece.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, unintentional user error caused or contributed to this event.No further action is required at this time.
Event or Problem Description
It was reported "we had an epidural catheter that broke off in a patient back during removal that i was able to still retrieve later on that morning." additional information received reports "after several hours an attempt was made with clamp to remove with gentle traction and it was successful.There was no issues relating to the patient.The residual catheter was removed with no patient harm." the patient's current condition is reported as "discharged home".

• Brand Name: ARROW 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20189216
• Report Number: 9680794-2024-00860
• Device Sequence Number: 8250572
• Product Code: BSO
• UDI-Device Identifier: 50801902013694
• UDI-Public: (01)50801902013694(11)240430(17)260331(10)33F24B0160(21)
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2024

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 Expiration Date: 03/31/2026
• Device Catalogue Number: SJ-05501
• Device Lot Number: 33F24B0160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/11/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2024
• 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