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

Model Number IPN920760

Device Problem Material Separation (1562)

Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/17/2022

Event Type  malfunction  

Event Description

During the removal of the epidural catheter 3 hours before giving birth, the catheter separated during the removal.It looks like 7 cm remained inside the female patient.There was no consequence for the patient.A scan has been requested to check the position of the part inside the patient.

Manufacturer Narrative

Qn# (b)(4).The device has not been returned for investigation.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter separated during removal.The customer returned one snaplock assembly, one epidural catheter piece, and lidstock.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 catheter appears used as adhesive material can be seen on the outer extrusion.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter piece using a ruler ((b)(4)).According to the customer, approximately 7cm of the catheter was left in the patient.The returned catheter extrusion measures approximately 92.5cm.The extrusion and coil wire are extremely stretched at the distal end of the catheter.Although, the measurement of what was returned falls just outside the specification of 88.5-91.5 cm per graphic (b)(4), the returned catheter was not in specification based on the evidence of stretching of the extrusion/coil wire and approximately 7cm of the catheter that was not returned.Specifications per graphic (b)(4) were reviewed as a part of this complaint investigation.The ifu for this kit, e-17019-110b; rev.1, was reviewed as a part of this complaint investigation.The ifu 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 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 separating 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 Description

During the removal of the epidural catheter 3 hours before giving birth, the catheter separated during the removal.It looks like 7 cm remained inside the female patient.There was no consequence for the patient.A scan has been requested to check the position of the part inside the patient.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• 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: 14829626
• MDR Text Key: 295153326
• Report Number: 3006425876-2022-00604
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 00801902029676
• UDI-Public: 00801902029676
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

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 Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: IPN920760
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F21M0488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 08/02/2022
• Supplement Dates FDA Received: 08/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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
• Treatment: N/A.