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

Catalog Number EC-05500

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the "catheter snapped upon removal and a section of epidural catheter was retained in the patient.Patient/anesthesia/ob provider were all notified immediately.Ob anesthesia notified.Patient in no distress with no neurological symptoms.Anesthesia ordered for patient to remain npo, to mark the site and cover with clear dressing.Patient had ct scan with retained catheter noted".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.

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.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 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 was not intact and was not returned.The returned catheter appeared used, as biological material was seen between the inner coils.No other defects or anomalies were observed.The customer also provided photos that showed a stretched epidural catheter.A dimensional inspection was performed on the returned catheter using a calibrated ruler.The returned catheter extrusion measured approximately 86.4cm.This indicated at least 2.1cm of the extrusion was missing as the specification for the epidural catheter indicated that the proper extrusion length of an epidural catheter was 88.5-91.5cm per product graphic.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 r e-attempt removal if resistance is encountered or if catheter stretches excessively during removal." a device history record review could not be performed as no valid lot number was provided by the customer for the reported kit.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 was required.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that the "catheter snapped upon removal and a section of epidural catheter was retained in the patient.Patient/anesthesia/ob provider were all notified immediately.Ob anesthesia notified.Patient in no distress with no neurological symptoms.Anesthesia ordered for patient to remain npo, to mark the site and cover with clear dressing.Patient had ct scan with retained catheter noted".The additional information on 15aug2023 reported that the catheter broke during the second attempt of removal and the section of catheter retained in the patient was not removed.The patient condition was stable and had no injury.

• Brand Name: EPIDURAL CATHETERIZATION COMPONENT
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17439319
• MDR Text Key: 320205188
• Report Number: 3006425876-2023-00733
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10801902200614
• UDI-Public: 10801902200614
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC-05500
• Device Lot Number: 33F23F0131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1