MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CATHETER REACT-71; CATHETER, PERCUTANEOUS

Model Number REACT-71

Device Problem Break (1069)

Patient Problems Infarction, Cerebral (1771); Device Embedded In Tissue or Plaque (3165)

Event Date 02/28/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the tip of the react catheter separated and remains in the patient's right m1.This event occurred during a mechanical thrombectomy case.The patient vessel remained open.Two react catheters were used and it is unknown which of these two device experienced the device separation.A851300 and a824582 were two devices that were used in the is case.

Manufacturer Narrative

D10: device available for evaluation - additional information g4.Date mfr rec ¿ additional information h2: type of follow up - device evaluation h3: device evaluated by manufacturer- additional information h6: codes updated the device was returned for evaluation and the clinical observation could not be confirmed.The react catheter total length and the useable length were found within specification.Upon visual inspection, no damages or irregularities were found with the react hub.The react-71 catheter body was found damaged from distal end.In addition, the catheter body was found damaged from distal end.The react-71 catheter distal tip/marker band was found damaged/deformed.The react-71 catheter was flushed, water exited from the distal end.No other anomalies were observed.Based on the device analysis and reported information, the react-71 catheter body was found damaged and distal tip was damaged/deformed not separated.However, the cause for the damage could not be determined.If information is provided in the future, a supplemental report will be issued.

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 indicated there were attempts made by the physician to remove the broken segment of catheter, but it was unsuccessful.The catheter was pretty well locked in place and so no additional intervention was performed to secure it in place.The patient did experience a slight stroke, but it remained uncertain how related it was to the device or an underlying condition.It was noted the patient was doing well now.

• Brand Name: CATHETER REACT-71
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9785447
• MDR Text Key: 183119649
• Report Number: 2029214-2020-00190
• 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: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2021
• Device Model Number: REACT-71
• Device Catalogue Number: REACT-71
• Device Lot Number: A851300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Date Manufacturer Received: 04/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention