MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REBAR; CATHETER, CONTINUOUS FLUSH

Model Number 105-5081-153

Device Problems Break (1069); Burst Container or Vessel (1074); Material Deformation (2976); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)

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

Event Date 11/28/2023

Event Type  malfunction  

Event Description

Medtronic received a report that the rebar catheter encountered resistance and was found broken when removed from the patient.The patient was undergoing cerebral vessel thrombectomy and stent placement for stenosis.The accessed vessel was the transfemoral artery with a diameter of 9 mm.It was noted the patient's vessel tortuosity was minimal.It was reported that used rebar, 68 and avigo coaxially to build the access into the skull for thrombus removal surgery.When the mi crocatheter was withdrawn out of the body, it was found that the rebar was damaged and the entire outer coating was broken.Then another rebar was replaced to complete the subsequent surgery.It was reported there was catheter resistance in the middle section.It was reported catheter rupture occurred during the angio.The catheter was broken in the middle section.There was no other damage to the catheter.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).The catheter was flushed as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.Ancillary devices include an avigo guidewire, react 68 catheter.

Manufacturer Narrative

Continuation of d10: product id 103-0606-200 (lot: b472202); product type: product id react-68 (lot: b522177); product type: 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 clarified that the rebar catheter encountered resistance with the react 68 catheter.There were no issues with the avigo guidewire or react catheter.

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.

Manufacturer Narrative

H3: product analysis: equipment used: vis (m-81805), 203cm ruler (m-83360).As found condition: the rebar-18 catheter was returned for analysis within a shipping box, a plastic bio-pouch, and an opened rebar-18 inner pouch (b526118).Damage location details: the pusher of an unknown non-medtronic stent device was found extending out from within the rebar-18 catheter hub for 33.0cm.No damages were found with the rebar-18 catheter hub.The rebar-18 catheter body was found separated at 146.2cm from the proximal end of the catheter hub (14.7cm from the catheter distal tip).The tubing material at the separated ends exhibited plastic deformation, indicating the catheter was separated likely due to tensile failure.No damages were found with the rebar-18 catheter distal tip.No bends or kinks were found with the unknown non-medtronic stent device pusher.The stent was found still attached to the pusher.The stent non-working and working length struts appear to be in good condition.Testing/analysis: the unknown non-medtronic stent device was found stuck within the rebar-18 catheter distal separated segment.The distal segment was dissected (cut) to remove the unknown non-medtronic stent device.¿ conclusion: based on the device analysis and reported information, the customer¿s ¿catheter resistance¿ and ¿catheter separation/break¿ reports were confirmed.The catheter can become separated if the unknown non-medtronic stent device is advanced against resistance, vasospasm, patient vessel tortuosity, entrapment in the vessel, or application of excessive force, thus exceeding the tensile strength of the tubing material.Catheter resistance can be caused by the use of incompatible devices, patient vessel tortuosity, device damage, insufficient catheter flushing, or lack of continuous flush.The patient's vessel tortuosity was minimal and the catheter was flushed prior to use, ruling out patient vessel tortuosity and insufficient catheter flushing as potential causes.Information regarding if there was any vasospasm or vessel entrapment or use of a continuous flush was not reported.The make/model of the non-medtronic stent device was not reported, so device compatibility could not be assessed.However, there do not appear to be any damages with the non-medtronic stent device that would have contributed to the reported event.The cause(s) of the reported event could not be determined.H6.Coding updated based on analysis results 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: REBAR
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18237860
• MDR Text Key: 329375715
• Report Number: 2029214-2023-02309
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 00847536026834
• UDI-Public: 00847536026834
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 105-5081-153
• Device Catalogue Number: 105-5081-153
• Device Lot Number: B526118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10...
• Patient Age: 72 YR
• Patient Sex: Female