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

Model Number	RFX072-115-08MP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the distal end of the intracranial support catheter was damaged and broken, with only a metal wire connecting it.The reported device and any accessory devices were prepared and the catheter was flushed as indicated in the instructions for use (ifu).No patient symptoms or complications were associated with this event.The patient was undergoing surgery for treatment of an intracranial aneurysm.It was noted the patient's vessel tortuosity was moderate.The accessed vessel was the right radial artery with a 4mm diameter.
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 reported the damage was not noticed upon opening the package.No preparation was performed prior to the damage being seen.There was no damage or evidence of tampering to device packaging.
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
Product analysis #806243574:¿ equipment used: vis (m-78210), 203cm ruler (m-83361) ¿ as found condition: the navien catheter was returned for analysis within a shipping box, a plastic bio-pouch, and an opened navien inner pouch (b468096).¿ damage location details: no damages were found with the navien catheter hub.The navien catheter was found kinked ~14.5cm from the proximal end of the catheter hub.The navien catheter body was found separated ~104.5cm from the proximal end of the catheter hub, ~18.0cm from the catheter distal tip, retained by the inner wire.The tubing material of the catheter separated end exhibited plastic deformation (jagged edges), indicating the catheter likely separated due to tensile failure.The navien catheter distal tip was found to be in good condition.¿ testing/analysis: none ¿ conclusion: based on the device analysis and reported information, the customer¿s ¿catheter separation/break¿ report was confirmed as the navien catheter body was found separated.Possible causes of ¿catheter separation/break¿ include advancing or retrieving the catheter against resistance, vasospasm, patient vessel tortuosity, entrapment in the vessel, fast catheter retrieval technique, or applying excessive force, thus exceeding the tensile strength of tubing material.However, the cause of the catheter separation 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SUPPORT GUIDECATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: 19152416
• Report Number: 2029214-2024-00713
• Device Sequence Number: 8434023
• Product Code: DQY
• UDI-Device Identifier: 00847536017924
• UDI-Public: 00847536017924
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K110055
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/08/2024

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: 10/25/2024
• Device Model Number: RFX072-115-08MP
• Device Catalogue Number: RFX072-115-08MP
• Device Lot Number: B468096
• 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: 04/18/2024
• Supplement Date Received by Manufacturer: 04/23/2024; 06/10/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 05/14/2024; 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2022
• 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 Age: 66 YR
• Patient Sex: Female
• Patient Weight: 78 KG