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

Model Number 190-5091-150

Device Problem Packaging Problem (3007)

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

Event Date 06/16/2023

Event Type  malfunction  

Manufacturer Narrative

H3: product analysis of 190-5091-150, lotno:b541773 visual inspection/damage location details: the echelon-10 total length was measured to be ~155.4cm.The echelon-10 useable length was measured to be ~147.6cm.Upon visual examination, no issues were found with the echelon-10 hub.No bends or kinks were found with the echelon-10 catheter body.However, saline residue was found on catheter body at ~0.5cm from separated tip.The distal marker band and distal tip were found to be separated and not returned.The tubing material of the catheter separated end exhibited stretching with jagged edges.No other anomalies were observed.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿prod damaged/deformed out of pkg¿ was confirmed; however, the broken end of the catheter exhibited plastic deformation (stretching and jagged edges) which indicate that the catheter separated when exceeding the tensile strength of the tubing material.In this event, user error likely contributed to the during the removal of the echelon-10 micro catheter tip from within the tip protector and then separated.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that an echelon 10 catheter tip had a stitch on it.While preparation of the catheter (flushing the catheter), there was a little stitch coming out of the catheter.The catheter was flushed as per instructions for use (ifu).The devices were prepared as per ifu.There was no patient involved with this event.There was no damage or evidence of tampering to device packaging.

• Brand Name: ECHELON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17542094
• MDR Text Key: 321153425
• Report Number: 2029214-2023-01372
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536006294
• UDI-Public: 00847536006294
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K042187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 190-5091-150
• Device Catalogue Number: 190-5091-150
• Device Lot Number: B541773
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1