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

Model Number REACT-71

Device Problems Stretched (1601); Deformation Due to Compressive Stress (2889); Device Damaged by Another Device (2915); Physical Resistance/Sticking (4012)

Patient Problem Vascular Dissection (3160)

Event Date 03/25/2021

Event Type  Injury  

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 experienced resistance and was damaged.The patient was undergoing treatment for a right m1 stroke.The patient anatomy was tortuous.It was reported that the doctor did one aspiration to m1 and removed some of the clot.The tech mentioned that the doctor ¿exerted himself¿ and at one point ¿couldn¿t get purchase¿ for second pass.It looked like distal end of react had folded on itself and that the microcatheter had punctured through it.The product got ripped out and the react may have gotten stretched in the process.There was difficulty going up the second time in the carotid. the catheter was replaced and the same thing happened with a second react catheter which was also replaced. the patient experienced a possible dissected carotid artery, and their status was said to be alive with no injury.Ancillary devices include a headway 27 microcatheter and synchro 2 guidewire.

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

Additional information received reported that it was unclear if the dissection was caused by the device, user/technique error, or if it was pre-existing.The devices were prepared according the instructions for use (ifu).As of 26-mar-2021 the patient was alive and stable.

Manufacturer Narrative

H3.Product analysis findings: the react-71 catheter was returned for analysis inside of a biohazard bag and a shipping box.There was no headway 27 catheter returned with the react-71 catheter.The total and usable lengths of the react 71 catheter were found within specifications.No damages were found with the catheter tip and marker band.However, the catheter body appeared to be stretched at 16.0cm to 28.0cm from the distal tip.In addition, the catheter body was also found to be kinked at 15.0cm, 39.0cm and 75.0cm from the catheter hub.No puncture hole was found on the catheter body.No damages or irregularities were found with the react 71 hub.The react-71 catheter appeared to be compatible for use with the headway 27 catheter as it has a labeled inner diameter (id) of 0.071".The react-71 catheter was flushed with water and found to be patent.The catheter was tested with an in-house 0.035" mandrel through hub with no issues.However, resistance was observed at the damaged locations.No other anomalies were observed.Based on the reported information and the device analysis, the customer¿s report of "catheter resistance" and "catheter kink/damage" were confirmed as the returned react-71 catheter was found to be stretched be kinked at several locations.It is possible the damage occurred when the customer attempted to advance the headway 27 catheter through the react-71 catheter against resistance.Possible causes include the use of damaged device, patient vessel tortuosity and lack of continuous flush with heparinized saline during delivery.There was no non-conformance to specifications identified that led to reported issue.Since the headway 27 catheter was not returned; any contribution of the catheter to the reported issues could not be determined.H6.Event coding updated based on analysis information.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: 11606682
• MDR Text Key: 243527866
• Report Number: 2029214-2021-00385
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00847536031784
• UDI-Public: 00847536031784
• Combination Product (y/n): N
• PMA/PMN Number: K182097
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/22/2022
• Device Model Number: REACT-71
• Device Catalogue Number: REACT-71
• Device Lot Number: B046834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2021
• Date Manufacturer Received: 06/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR