MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. SWIFTNINJA STEERABLE MICROCATHETER; CATHETER, CONTINUOUS FLUSH

Catalog Number MIV-20500

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900); Output Problem (3005)

Patient Problem Unintended Radiation Exposure (4565)

Event Date 06/04/2021

Event Type  Injury  

Event Description

During the administration of y90 embolic beads during treatment, it was noticed there was leakage of the treatment around the end of the treatment catheter.The physician and pa noticed and immediately stopped administration.Physician checked all connections and visually inspected the catheter for obvious catheter damage.Noticed no issues with connection.The malfunction was at the catheter and guidance mechanism connection.The injection was terminated and catheter removed from patient and wasted accordingly under direct supervision with nuclear medicine technologist.Immediately procedure was paused and staff inspected for safety/exposure with gieger counter.Everything was wasted and scanned safely by nm tech before allowed to leave the room.Patient was safely removed from room and transferred to post procedure scan with nurse monitoring.Radiation safety officer arrived and began room decontamination process.Fda safety report id# (b)(4).

• Brand Name: SWIFTNINJA STEERABLE MICROCATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC. ; south jordan UT 84095
• MDR Report Key: 11982914
• MDR Text Key: 255961057
• Report Number: MW5101829
• Device Sequence Number: 1
• Product Code: KRA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2024
• Device Catalogue Number: MIV-20500
• Device Lot Number: H2058694
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Weight: 128