MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. ECHELON 10 CATHETER; CATHETER, CONTINUOUS FLUSH

Model Number 105-5091-150

Patient Problem Insufficient Information (4580)

Event Date 02/04/2024

Event Type  malfunction  

Event Description

Transarterial embolization of the occipital artery performed.Distal access into the right occipital artery was obtained with an echelon 10 microcatheter and synchro 2 microwire.Microcatheter run demonstrated good positioning of the microcatheter.The catheter was then flushed with dmso and onyx18 was then slowly injected under constant fluoroscopic guidance utilizing a blank roadmap.Three vials of onyx 18 was used with care to avoid reflux as we embolized back to the intermediate catheter.Periodic runs were performed confirming progressive embolization with significant reduction in supply to the fistula.At this point, we elected to conclude the procedure and performed a staged approach to treatment of this complex fistula with multiple feeders.We attempted to withdraw the echelon 10 microcatheter; however, there was significant resistance and ultimately the catheter fractured.Remnant catheter was observed within the intermediate catheter down into the common carotid artery.We attempted to use a glidewire to push the remnant catheter up into the occipital artery; however, the wire was sliding past the catheter.The pxs slim microcatheter was then introduced into the sofia and was noted to capture the remnant echelon 10 microcatheter.The pxs slim microcatheter was then advanced into the occipital artery and a wire was used to push out the echelon 10 microcatheter which was noted to be coiled in the occipital artery.Final runs were performed demonstrating no evidence of any thromboembolic complications and decreased filling of the fistula.

• Brand Name: ECHELON 10 CATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC.; 5290 california avenue; irvine CA 92617
• MDR Report Key: 18776917
• MDR Text Key: 336207004
• Report Number: 18776917
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 105-5091-150
• Device Catalogue Number: 105-5091-150
• Device Lot Number: B456169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/09/2024
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White