MAUDE Adverse Event Report: ARROW INTERNATIONAL SUBSIDIARY OF TELEFLEX ARROW THERACATH EPIDURAL CATHETER; ANESTHESIA CONDUCTION KIT

Model Number MM-05001

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/25/2022

Event Type  malfunction  

Event Description

Arrow theracath epidural catheter placed on (b)(6) 2022 for pain management during brachytherapy cancer treatment, removed after treatment on (b)(6) 2022.Mri later demonstrated an incidental finding of a metallic foreign body at l5-s1 on (b)(6) 2022.Fda safety report id# (b)(4).

• Brand Name: ARROW THERACATH EPIDURAL CATHETER
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL SUBSIDIARY OF TELEFLEX; morrisville NC 27560
• MDR Report Key: 14416703
• MDR Text Key: 291982598
• Report Number: MW5109746
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: MM-05001
• Device Lot Number: 13F21M0266
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White