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

Model Number REACT-68

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 08/28/2020

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 68 catheter fractured in the patient, and the segment was removed via surgical intervention.The patient was undergoing surgery for treatment of acute right m1 stroke.It was reported that the solitaire and ancillary devices were prepared and deployed per the instructions for use (ifu), and then the solitaire was brought up to the react catheter to start aspiration.It was then noticed the react catheter had become fractured at the distal end.The physician tried to remove the entire system, but the end of the catheter remained inside the patient.The m1 was now open and free of clot at this point.Another solitaire was used to try and retrieve the catheter piece, but it was unsuccessful.After several attempts, the physician was able to remove the catheter from the cerebral circulation, but it became lodged in the right radial artery.It was decided the best way to remove the catheter was by way of surgical cut down.This was successful, and the fractured catheter was removed from the patient.The artery was closed without issue and the patient was doing very well and showed recovery of the m1 stroke they presented with.No additional issues were noted due to the catheter fracture.Additional information received reporting that no resistance was noted during delivery or retrieval of the stent, everything felt normal.The patient's baseline nihss was 18.The physician reported that the patient's condition was improved and the patient continued to do very well.

Event Description

No additional information received.

Manufacturer Narrative

H3: analysis of the react-68 catheter (model: react-68 lot: a781182) found no damages or irregularities with the react-68 hub.Dried blood was found within the hub.The react-68 catheter lumen was found kinked at ~7.0cm from the proximal end.The distal ~39.2cm segment of the react-68 catheter was found stretched/accordion.The react-68 catheter distal end was found separated with the inner coil wire exposed and the inner liner found stretched.The tubing material of the react-68 catheter separated end exhibited with stretching and jagged edge.The distal segment was not returned.The react-68 catheter total length was measured to be ~146.3cm which is not within specification (specification: 141cm ± 3cm) and the useable length was measured to be ~139.8cm which is not within specification (specification: 132cm +3/-0cm).No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿catheter separation/break¿ was confirmed.The broken end of the react-68 catheter exhibited with plastic deformation (jagged edges and stretching) which indicated that the catheter separated when exceeding the tensile strength of the tubing material.In addition, the distal catheter was found accordioned and stretched.Possible causes for failure are, user advances/retrieves intraluminal device against resistance, vasospasm, patient vessel tortuosity, entrapment in vessel, or user applies excess ive force, thus exceeding tensile strength of tubing material.As the solitaire used during the event was not returned, any contribution of the solitaire towards the catheter separation/break¿ could not be determined.The catheter total and usable length were found out of specification.The likely cause is the catheter was stretched beyond the specification.H6: conclusion code updated to d15.Result code updated to c070601 and c070603.Method code updated to b01.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: 10547898
• MDR Text Key: 207364964
• Report Number: 2029214-2020-00941
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00847536031777
• UDI-Public: 00847536031777
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/10/2021
• Device Model Number: REACT-68
• Device Catalogue Number: REACT-68
• Device Lot Number: A781182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR