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

Model Number	190-5091-150
Medical Device Problem Codes	Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is reported at this time based on analysis results which indicated a reportable event.H3.Product analysis: equipment used: vis (m-81805), 203cm ruler (m-83361) as found condition (condition of returned device): an echelon-10 micro catheter was returned for analysis within a shipping box; within a sealed biohazard pouch and within a sealed tyvek pouch.Visual inspection/damage location details: the echelon-10 total length was measured to be ~154.8cm.The echelon-10 useable length was measured to be ~146.9cm.Upon visual examination, no issues were found with the echelon-10 hub; however, what appeared to be saline residue was found within hub.The echelon-10 catheter body was found to be kinked at ~118.3cm from distal end.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.A formal investigation regarding this issue was previously conducted.Based on the formal investigation, potential sources of this issue are either improper product packaging, during manufacturing or improper removal of the product from packaging by the end user.However, the cause for the damage could not be determined.Based on the reported information and the device analysis the customer¿s report of ¿catheter kink/damage¿ was able to be confirmed; however, the root cause was unable to be determined.Possible cause for ¿catheter kink/damage¿ is delivery system removed aggressively.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information reporting that when the echelon 10 catheter package was open the catheter was found to have a kink at the distal end.There was no patient involved.Additional information received reported there was not any damage to the device packaging in the procedure.

• Brand Name: ECHELON
• Common Device Name: 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: 14431207
• Report Number: 2029214-2022-00838
• Device Sequence Number: 20491773
• Product Code: KRA
• UDI-Device Identifier: 00847536006294
• UDI-Public: 00847536006294
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K042187
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/17/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/02/2023
• Device Model Number: 190-5091-150
• Device Catalogue Number: 190-5091-150
• Device Lot Number: B275399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 05/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown