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

Model Number REACT-68

Device Problems Device Damaged by Another Device (2915); Physical Resistance/Sticking (4012)

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

Event Date 04/11/2021

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 advanced to the petrous segment of the internal carotid artery (ica).The physician advanced the trevo pro 18 microcatheter and trevo pro vue inside the react aspiration catheter and there was resistance felt.The physician was not happy with the angiographic appearance, so the system was removed.It was then noticed the side of the catheter was ruptured in the distal segment.No other device damage was observed/reported.A replacement product was used to compete the procedure.It was indicated that all devices were prepared 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 mechanical thrombectomy with significant vessel tortuosity.Ancillary devices include a trevo pro 18 microcatheter and trevo pro vue 4 x 20 stentriever.

Manufacturer Narrative

H3.Product analysis findings: the react-68 catheter was returned for analysis within a shipping box; within two sealed biohazard pouches; within an unsealed plastic pouch and without a dispenser coil.The non-medtronic microcatheter was found within the react-68 catheter.The non-medtronic stentriever used in the event was not returned for analysis.No damages or irregularities were found with the react-18 catheter hub.Dried blood was found within the hub.The react-68 catheter body was found kinked and ruptured at ~5.0cm from the distal end.The catheter was found accordioned at ~3.5cm from the distal end.The distal tip and marker band was found slightly crushed.The react-68 total length was measured to be ~144.0cm (specification 141cm ± 3cm), the usable length was measured to be ~133.8cm which is within specification (specification 132cm +3cm/-0cm).The react-68 catheter was flushed, and water was found to exit slowly out of the rupture.The non-medtronic microcatheter was found stuck within the react-68 catheter.The react-68 catheter became accordioned further and the ruptured section became more severe during the microcatheter extraction.Dried blood was found within the react-68 catheter and throughout the microcatheter.An in-house mandrel was inserted into the react-68 catheter hub and through the catheter against resistance and the mandrel became stuck at the accordioned location.Dried blood was found on the mandrel when removed following resistance testing.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿catheter resistance¿ and ¿catheter rupture¿ were confirmed.In-house resistance testing found resistance throughout the catheter and at the damaged areas.The likely cause of the resistance is the blood found within the catheter.It is possible that insufficient continuous flush was used, causing blood to backflow up the catheter and coagulate, causing resistance.Other potential causes for catheter resistance are patient vessel tortuosity, material occludes catheter, intraluminal device damage or lack of hydration prior to use.It is possible the catheter accordioning and catheter rupture occurred due to manipulation of the devices against the reported resistance as the damage became exacerbated during extraction of the micro catheter against resistance.Other possible causes are device navigated within the guide catheter too aggressively, or guidewire is inserted without checking catheter integrity/catheter patency.The non-medtronic microcatheter has an outer diameter of 0.021¿ which is compatible for use with the react-68 catheter.As the non-medtronic stentriever was not returned, any contribution of the stentriever towards the catheter resistance and catheter rupture could not be assessed.There is no evidence suggesting that the react-68 catheter was defective.There was no indication that the event was related to a potential manufacturing issue.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: 11684803
• MDR Text Key: 246012036
• Report Number: 2029214-2021-00449
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2021
• Device Model Number: REACT-68
• Device Catalogue Number: REACT-68
• Device Lot Number: A906343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2021
• Date Manufacturer Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1