MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ECHELON; CATHETER, CONTINUOUS FLUSH

Model Number 190-5091-150

Device Problems Material Deformation (2976); Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/19/2021

Event Type  malfunction  

Event Description

Medtronic received information regarding an echelon catheter that had wire drawing damage. it was reported that the patient was undergoing a coil embolization procedure to treat a middle cerebral artery (mca) aneurysm.The guide catheter was in place.The echelon-10 microcatheter was opened and was found to have wire drawing damage at the distal tip.The catheter was replaced and the replacement catheter was used to successfully place 3 coils to complete the procedure without further issue.There was no harm or injury to the patient.Additional information received reported that the damage was noticed as soon as the package was opened.After the surgeon opened the package and found the problem, they did not used it and replaced it with a new microcatheter.

Manufacturer Narrative

The event is reported at this time based on analysis results.Product analysis: the echelon-10 micro catheter was returned for analysis within a shipping box and within a sealed plastic biohazard pouch.The packaging was not returned for analysis.No flash or hub mold were found within the hub.No damages or irregularities were found with the echelon-10 hub.No damages were found along the echelon-10 micro catheter length.The distal tip and marker band were found separated from the echelon-10 micro catheter and not returned for analysis.The inner liner was found stretched, protruding out of the break.The echelon-10 total length was measured to be ~152.6cm and the useable length was measured to be ~144.8cm which is within specification (specification: total (ref) = 152cm; usable = 144cm ± 1.5cm).Based on the device analysis and reported information, the customer¿s report of ¿catheter kink/damage¿ was confirmed.The echelon-10 micro catheter distal marker band and distal tip were found separate.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.Based on the formal investigation, the failure mode was able to be re-created by p inching the tip protector in the wrong direction.This is caused by pinching the tip protector closed instead of pinching it open as the ifu and image on the packaging instructs.It was not possible to determine if the tip became damaged during packaging or while removing the catheter from the packaging.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ECHELON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 12551278
• MDR Text Key: 282417624
• Report Number: 2029214-2021-01224
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536006294
• UDI-Public: 00847536006294
• Combination Product (y/n): N
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2022
• Device Model Number: 190-5091-150
• Device Catalogue Number: 190-5091-150
• Device Lot Number: B089314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Date Manufacturer Received: 09/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1