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

Catalog Number	BP-05501
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "while attempting to remove epidural catheter, the catheter broke.It was determined that surgery is needed to remove the flextip plus catheter due to a concern the catheter might migrate if left in patient.Surgery scheduled for week of (b)(6) 2024.Patient as i know it is fine, but still need surgery to remove the catheter and that has not happened yet".At the time of this report, the customer has not returned our requests for additional information.
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).Additional information received indicates "patient required laminectomy to remove retained catheter".It was also reported that the patient did not experience any signs or symptoms due to this event, and the condition of the patient was "stable".The actual device was not returned; however, the customer did provide a photo that appears to show a separated catheter.A device history record review was performed on the epidural catheter with no relevant findings.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural catheter with no relevant findings.The customer did provide a photo that appears to show a separated catheter; however, the potential cause of this complaint could not be determined based upon the information provided and without a sample.No further action is required at this time.Other remarks: n/a, corrected data: n/a.
Event or Problem Description
It was reported that "while attempting to remove epidural catheter, the catheter broke.It was determined that surgery is needed to remove the flextip plus catheter due to a concern the catheter might migrate if left in patient.Surgery scheduled for week of (b)(6) 2024.Patient as i know it is fine, but still need surgery to remove the catheter and that has not happened yet".

• Brand Name: 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: 18837690
• Report Number: 9680794-2024-00217
• Device Sequence Number: 15238974
• Product Code: BSO
• UDI-Device Identifier: 50801902007457
• UDI-Public: 50801902007457
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2024

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: BP-05501
• Device Lot Number: 33F23I0385
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 04/04/2024
• 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
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 64 KG