MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REACT CATHETER; CATHETER, PERCUTANEOUS

Model Number REACT-68

Device Problems Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 06/01/2021

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 the react catheter was guided to the internal carotid artery (ica) by a rebar-18 microcatheter and avigo guidewire.When the catheter went to the siphon bay of the ica, the surgeon felt that it was difficult to deliver the catheter.After many unsuccessful attempts, the entire system was withdrawn.Upon inspection, it was found the react catheter was bent 2-3 cm from the tip side, and there were two or three catheter color differences.The surgeon considered the inner layer of the catheter was separated from the outer layer or the inner structure was broken and separated.A replacement react catheter was used to complete the procedure.It was indicated that all devices were prepared/flushed as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The patient was undergoing emergency surgery for a thrombectomy of an acute occlusion of the right ica with unknown vessel tortuosity.

Event Description

Additional information received reported there was no vasospasm during the procedure.No excessive force was applied during delivery or retrieval of the catheter.The healthcare provider used the coaxial technology to push upward with the micro-guide wire and the micro-catheter, and withdrew the system in time once resistance was felt.

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.

Manufacturer Narrative

H3: the react 68 catheter was returned for analysis.The react 68 catheter hub was found in good condition.The react 68 catheter body was found damaged at ~2.8cm and ~2.2cm from the distal tip.The react 68 distal tip was found in good condition.The react 68 catheter body was dissected (cut) at the damaged locations.The inner wire was found intact; however, the inner liner was found delaminated.No breaks or separations were found with the react 68 catheter.The react 68 catheter total length was measured to be ~140.2cmand the useable length was measured to be ~133.5cm which is within specifications (specification: 132cm +3/-0cm).Based on the device analysis and reported information, the customer¿s ¿catheter kink/damage¿ report was confirmed.However, the customer¿s ¿catheter separation/break¿ and ¿difficult navigation¿ reports could not be confirmed.It is possible the difficulty navigating the react 68 catheter contributed to the damages found with the react 68 catheter.Difficult navigation can be caused by difficult patient anatomy; however, information regarding patient vessel tortuosity was not provided and the cause could not be determined.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: REACT CATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11938185
• MDR Text Key: 254314752
• Report Number: 2029214-2021-00663
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00847536041967
• UDI-Public: 00847536041967
• Combination Product (y/n): N
• PMA/PMN Number: K180715
• 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: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2022
• Device Model Number: REACT-68
• Device Catalogue Number: REACT-68
• Device Lot Number: B055863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Date Manufacturer Received: 09/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 68