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

Model Number 105-5091-150

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 09/05/2022

Event Type  malfunction  

Manufacturer Narrative

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 catheter was not visible.Only the tip marker could not be visually confirmed when it was run alongside the guidewire and delivered the corresponding product, estron 10, to the front of the lesion region.The attending physician as well as the sales representative of a distributor who was present could not visually confirm the event.It was determined to be a defect, so it was collected and resolved with the same model.The device was prepared as indicated in he package insert.The event was not associated with a patient.  ancillary devices: chikai ain-cki-200r lot: 220312a01a guidewire.

Manufacturer Narrative

H3: product analysis #705197726:¿ equipment used: vis (m-81805), 203cm ruler (m-83360) ¿ drawing(s) referenced: dwgs105-5091-150 rev.Ay ¿ as found condition: the echelon-10 micro catheter was returned for analysis within a shipping box and within plastic pouches.¿ visual inspection/damage location details: upon visual inspection, no damages or irregularities were found with the catheter hub.No bends or kinks were found with the catheter body.The catheter distal tip was found bent.The characteristic of the bent catheter distal tip is consistent with tip shaping.The catheter distal marker/tip was found separated and missing.The outer and inner tubing material at the separated end exhibited with jagged edges and stretching.The inner elliptical wire at the separated end was found exposed.¿ testing/analysis: the echelon-10 micro catheter was flushed, blood and water exited from the distal tip.An in-house mandrel was inserted into the catheter hub and through the distal separated end without issue.The distance from the distal edge of the proximal marker band to the distal separated end was measured to be 29.4mm (specification: 31.3mm ± 1.0mm).Approximately 0.9mm-2.9mm of the catheter distal marker/tip was found missing and not returned.¿ conclusion: based on the device analysis and reported information, the customer¿s ¿marker band dislodged¿ report was confirmed.The echelon-10 micro catheter distal marker/tip was found separated and not returned.Possible causes of ¿marker band dislodged¿ include tensile failure, user operational context if user advances or retrieves intraluminal device against resistance, vessel tortuosity, kink/damage in guide catheter/sheath, balloon guide catheter, guidewire/stents which may have contributed to resistance during delivery and/or withdrawal/re-sheathing process, hard clots/calcifications in the navigation tract which may snag the catheter, or catheter tip shaping.The plastic deformation of the tubing material (jagged edges/stretching) indicates that the catheter tip separated as the tensile strength of the tubing material was exceeded.The separated distal marker/tip was not returned; therefore, any contributing factors (such as marker band damage) could not be assessed.As there appears to have been shaping performed to the echelon-10 catheter distal tip it is possible the distal marker/tip became damaged/separated during shaping.However, the root cause for the marker separation could not be determined.(rosaj10 2022-10-24) 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
• 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: 15474571
• MDR Text Key: 306325055
• Report Number: 2029214-2022-01612
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00836462002241
• UDI-Public: 00836462002241
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2024
• Device Model Number: 105-5091-150
• Device Catalogue Number: 105-5091-150
• Device Lot Number: B361913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2022
• 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