MAUDE Adverse Event Report: COVIDIEN (IRVINE) REACT 68; CATHETER, THROMBUS RETRIEVER

Model Number	REACT-68
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The react 68 catheter was returned for analysis without the penumbra velocity microcatheter and solitaire (4x40) revascularization device.From known measurement of the penumbra velocity microcatheter, it appears that the velocity microcatheter is compatible for use with the react 68 catheter.The react 68 catheter was decontaminated.Upon visual inspection, no damages or irregularities were found with the react 68 hub or body.However, the react 68 distal marker band/tip was found missing.The tubing material of the react 68 catheter separated end exhibited with stretching and jagged edges with the inner wire stretched and exposed.The react 68 distal marker band/tip was not returned.This segment was reported to have been removed from the patient and was expected to be returned.However, it was not received, it is likely to have been lost.Due to its damaged condition, the react 68 catheter could not be used for resistance testing.No other anomalies were observed.Based on the device analysis and reported information, the report of ¿catheter separation/break¿, the issue was confirmed.The broken end of the catheter exhibited with plastic deformation (jagged edges and stretching) which indicated that the catheter separated when exceeding the tensile strength of the tubing material.It is possible the react 68 catheter became damaged during delivery of the velocity micro catheter; subsequently causing the catheter to separate.However, the root cause for the resistance and separation could not be determined.Per our device's instructions for use (ifu): "the catheter should be manipulated under fluoroscopy only.Do not attempt to move the catheter without observing the resultant tip response." "never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel." if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that after the second pass, the react 68 catheter was noted to have fallen apart.The catheter was reported to have felt sticky with the velocity microcatheter.Resistance was felt when navigating with the react and when it was used with the guidewire.During the 1st pass, there was some difficulty pulling the velocity microcatheter out of the react while the stent was deployed (more than usual).On the second pass, pulled the solitaire 4x40 stent and react together.The distal section of the react was noted to have fell apart.However, were able to removed the portion of the catheter that sheared off.This event occurred during an occlusion in the posterior.A continuous flush was used and all the catheters were flushed.There was no allegation that the device were noted to have been damaged prior to their use.The react and the separated tip will be returned for analysis.The patient anatomy was straightforward with minimal tortuosity.

• Brand Name: REACT 68
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 8278601
• Report Number: 2029214-2019-00056
• Device Sequence Number: 13978261
• Product Code: NRY
• UDI-Device Identifier: 00847536031777
• UDI-Public: 00847536031777
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K180705
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/25/2019

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: 08/28/2020
• Device Model Number: REACT-68
• Device Lot Number: A700056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 01/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1