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

Model Number	REACT-68
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Medtronic received a report that the solitaire 4/40 was placed in the m2 region of the patient.The react 68 was advanced over solitaire wire into the m2 region to engage clot.Both devices were removed together under suction.The physician noticed the solitaire had been twisted inside react but otherwise was intact.A second pass was attempted with the same react 68 but a new solitaire 4/40.The same position in the m2 was achieved.The physician again removed both devices.Tici 3 was achieved but the physician noticed the distal end of the react was compromised.The physician confirmed there were no catheter fragments in patient and ended the case.Catheter separation/break occurred in the distal section during use.There was no friction or difficulty during injection.There was no force applied during delivery or removal.  the catheter tip was not entrapped/stuck.There was no vasospasm.The catheter was not stuck inside the guide catheter.There was no surgical or medicinal intervention required.Broken segments were removed from the patient.The reported device and any accessory devices were prepared as indicated in the ifu.The catheter was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event. the patient was undergoing endovascular stroke thrombectomy using a mechanical thrombectomy device.It was noted the access vessel was the m2 with 3.5 mm diameter.Ancillary devices include a cook ksaw-6.0-39-90-rb-shtl-flex-hc sheath, react 68 guide catheter, vel 160str microcatheter, synchro2 guidewire and a sfr4-4-40-10.

• Brand Name: REACT CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 15788833
• Report Number: 2029214-2022-01926
• Device Sequence Number: 5612971
• Product Code: DQY
• UDI-Device Identifier: 00847536031777
• UDI-Public: 00847536031777
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K180715
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2022

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: 10/07/2023
• Device Model Number: REACT-68
• Device Catalogue Number: REACT-68
• Device Lot Number: B282309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Initial Report FDA Received Date: 11/14/2022
• Date Device Manufactured: 10/15/2021
• 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 Age: 44 YR
• Patient Sex: Male