MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION KIT: 19 GA; ANESTHESIA CONDUCTION CATHETER

Model Number	IPN925039
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that the nurse attempted to remove the catheter but met resistance.She repositioned the patient and attempted again.Excessive force was not used and when she pulled on the catheter it snapped.The crna ordered a ct scan which confirmed an approximately 1 inch retained portion of the catheter to be located in the epidural space.The fragment of retained catheter was not removed.The patient was discharged home with precautions.
Additional Manufacturer Narrative
(b)(4).The reported complaint of epidural catheter breaking during removal was confirmed based upon the sample received.The customer returned one snaplock assembly and one epidural catheter piece.The returned components were received connected to each other.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.The proximal end of the catheter was returned and was revealed to be intact upon visual inspection.The returned catheter piece also revealed 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 catheter appears to have been used, as evidenced by the presence of biological material between the inner coils and adhesive material on the outer extrusion.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter piece via a calibrated ruler and the catheter extrusion measured approximately 85.6cm.This indicates at least 2.9cm 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.Additionally, 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." a device history record review could not be performed as no lot number was provided by the customer.A review of sales history data was performed to obtain a lot number.However, there was no record of purchase of this product by this customer.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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that the nurse attempted to remove the catheter but met resistance.She repositioned the patient and attempted again.Excessive force was not used and when she pulled on the catheter it snapped.The crna ordered a ct scan which confirmed an approximately 1 inch retained portion of the catheter to be located in the epidural space.The fragment of retained catheter was not removed.The patient was discharged home with precautions.

• Brand Name: EPIDURAL CATHETERIZATION KIT: 19 GA
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL LLC; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 16923591
• Report Number: 3013162291-2023-00001
• Device Sequence Number: 6930435
• Product Code: BSO
• UDI-Device Identifier: 10801902210224
• UDI-Public: 10801902210224
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 04/21/2023

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
• Operator of Device: Health Professional
• Device Model Number: IPN925039
• Device Catalogue Number: MP-17019-TKL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 06/06/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: N/A.; N/A.
• Patient Sex: Female