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

Catalog Number	EC-05500
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn # (b)(4).
Event or Problem Description
It was reported that: "at the end of the surgical procedure an epidural catheter was put in place (paravertebral block) for pain control by dr.After the surgical incision was closed it was determined that the paravertebral block was not working, and the epidural catheter was removed.In doing so it was noted by dr.That a portion of the catheter tip was missing and still inside the patient.A chest xray was ordered.The thoracotomy closure was reopened and the chest cavity was searched.The missing catheter portion was located and an intra operative chest xray was performed to determine the catheters completion.Dr.Agreed that the epidural catheter was completely removed from the patient the patient's right thoracotomy incision was reclosed and or counts were performed as per nursing standards ".
Event or Problem Description
It was reported that: "at the end of the surgical procedure an epidural catheter was put in place (paravertebral block) for pain control by dr.After the surgical incision was closed it was determined that the paravertebral block was not working, and the epidural catheter was removed.In doing so it was noted by dr.That a portion of the catheter tip was missing and still inside the patient.A chest xray was ordered.The thoracotomy closure was reopened and the chest cavity was searched.The missing catheter portion was located and an intra operative chest xray was performed to determine the catheters completion.Dr.Agreed that the epidural catheter was completely removed from the patient the patient's right thoracotomy incision was reclosed and or counts were performed as per nursing standards ".
Additional Manufacturer Narrative
(b)(4).Udi number unavailable as complainant did not report a lot number.Complaint verification testing could not be performed as it was reported that the sample is not available for return.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: EPIDURAL CATHETERIZATION COMPONENT
• Common Device Name: 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19285729
• Report Number: 3006425876-2024-00505
• Device Sequence Number: 15543937
• Product Code: BSO
• UDI-Device Identifier: 00801902003447
• UDI-Public: 00801902003447
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/29/2024

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 Catalogue Number: EC-05500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown