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

Model Number	105-5092-150
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Only echelon 14 catheter hub was returned for evaluation within its inner pouch; inside a biohazard bag and a shipping box.The hub appeared to be cut.The rest of the echelon 14 catheter segment was not returned.The reason for not returning was not provided.The neuroform atlas stent appeared to be damaged and stuck inside the echelon 14 catheter hub.The stent could not be pushed forward or removed from the catheter hub.Per stryker, the neuroform atlas is compatible for use with catheter id of 0.0165" or 0.017".Therefore, the neuroform atlas stent appeared to be compatible for use with echelon 14 catheter as it has an id of 0.017".No other anomalies were observed.Based on the returned device, the echelon 14 catheter was confirmed to have "catheter resistance at hub" issue.However, the root cause could not be determined as the echelon 14 catheter hub was returned with the neuroform atlas stent stuck inside the catheter hub.The stent appeared to be damaged and it could not be removed from the catheter hub.Therefore, resistance testing could not be performed.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that when trying to introduce a neuroform atlas stent into the echelon microcatheter, the stent became stuck in the hub.The echelon was removed and replaced by an sl-10 microcatheter, and the procedure was completed with no further issues.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.Ancillary devices include a neuroform atlas stent.

• Brand Name: ECHELON
• Common Device Name: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10964089
• Report Number: 2029214-2020-01244
• Device Sequence Number: 4168879
• Product Code: KRA
• UDI-Device Identifier: 00847536005983
• UDI-Public: 00847536005983
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K093750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2020

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: 02/04/2022
• Device Model Number: 105-5092-150
• Device Catalogue Number: 105-5092-150
• Device Lot Number: A971373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1