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

Model Number	105-5083-153
Medical Device Problem Codes	Burst Container or Vessel (1074); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Intracranial Hemorrhage (1891); Rupture (2208); Clinical Endoleak (4843)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that the rebar was placed in corresponding position, 0.6ml of dmso was flushed to fill the dead space of the rebar.When injecting the onyx, high pressure was felt at the moment and after applying pressure, the syringe with onyx ruptured between the hub of the catheter, and it was discovered that the vessel ruptured and caused bleeding.There was catheter rupture with onyx.The rupture location was distal.There was friction or difficulty during delivery.Aside from the rupture, there was no other damage to the catheter.The injection rate was 0.25ml per 90seconds.No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of type ii endoleak.It was noted the patient's vessel tortuosity was moderate.The access vessel was right lumbar with a diameter of 2mm.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received that it was clarified that glue embolization is done to combat the bleeding after rupture.The cause of the issue was not determined.The physician paused when the high pressure was felt, then they continued to inject afterwards then it ruptured.The injection rate was followed as indicated in the competitor's ifu, 0.25ml per 90s.The liquid embolic agent did not get embedded in an unintended location.This event did not required medical intervention.
Additional Manufacturer Narrative
Product analysis: ¿ as found condition: the rebar-18 catheter was returned for analysis within a shipping box and a plastic pouch.¿ damage location details: onyx residue was found within the rebar-18 catheter hub.No damages were found with the rebar-18 catheter hub.No bends or kinks were found with the rebar-18 catheter body.The rebar-18 catheter distal tip was found ovalized.No onyx was found with the rebar-18 catheter distal tip lumen.No ruptures were found with the rebar-18 catheter body.¿ testing/analysis: none ¿ conclusion: based on the device analysis and reported information, the customer¿s ¿resistance¿ and ¿catheter rupture¿ reports could not be confirmed, and the cause could not be determined.The returned rebar-18 catheter was found occluded with onyx; however, no ruptures were found.It is possible the catheter ovalizing contributed to the reported difficulty during the onyx injection; however, the cause could not be determined.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: REBAR
• Common Device Name: 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 19360419
• Report Number: 2029214-2024-00952
• Device Sequence Number: 6341910
• Product Code: KRA
• UDI-Device Identifier: 00836462002234
• UDI-Public: 00836462002234
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K093750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 11/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2025
• Device Model Number: 105-5083-153
• Device Catalogue Number: 105-5083-153
• Device Lot Number: B664880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: Not provided; 07/01/2024; 09/10/2024; 11/08/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 06/18/2024; 07/26/2024; 09/10/2024; 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male