MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ECHELON 10 90 PRE-SHAPED TIP; CATHETER, CONTINUOUS FLUSH

Model Number 190-5091-150

Device Problems Device Dislodged or Dislocated (2923); Packaging Problem (3007)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that when the physician pushed the echelon microcatheter, it was realized the second marker was missing.A new catheter was then used for the procedure.It was reported the catheter was flushed and prepared as indicated in the instructions for use (ifu).There was no patient involvement associated to the event.

Event Description

Medtronic received some additional information.It was reported from physician that he detected the missing distal marker, when he wanted to detach the first coil.He checked with fluoroscope the artery, but didn´t detect a marker band.

Manufacturer Narrative

B5: event description - additional information the device was not returned; therefore, product analysis cannot be performed.However, the device is expected to be returned.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.

Manufacturer Narrative

The total length of the echelon-10 micro catheter was measured to be within specifications.Upon visual inspection, no issues or irr egularities were found with the echelon-10 micro catheter hub.The catheter body appeared to be kinked at ~50.0cm and 57.0cm from the catheter hub.The echelon-10 micro catheter distal tip was noted pre-shaped.The echelon-10 micro catheter distal tip was found to be separated.The outer and inner tubing material at the broken end exhibited with jagged edges and stretching.The inner elliptical wire at the distal broken end was found to be exposed.Approximately 2.0mm of the distal tip and marker band were found missing.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿marker band dislodge¿ was confirmed as a portion of the distal tip and marker band were found missing.However, the cause for the separation could not be determined.The separated end of the echelon-10 micro catheter exhibited jagged edges and stretching which indicate that the catheter separated when exceeding the tensile strength of the tubing material.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.

• Brand Name: ECHELON 10 90 PRE-SHAPED TIP
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 10396661
• MDR Text Key: 202990519
• Report Number: 2029214-2020-00790
• 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,Followup,Followup
• Report Date: 10/23/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2021
• Device Model Number: 190-5091-150
• Device Catalogue Number: 190-5091-150
• Device Lot Number: A896637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 08/12/2020
• Supplement Dates Manufacturer Received: 08/13/2020; 09/23/2020
• Supplement Dates FDA Received: 08/21/2020; 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1