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

Model Number	FA-55150-1030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the patient submitted to embolization of the ophthalmic segment of the right internal carotid artery.Selective catheterization was performed using navien's advanced intracranial support catheter.The microguide was advanced distally to the dilation and posteriorly the marksman microcatheter distally.Irrigation of the pipeline stent in the y connector was initiated.The system was advanced in a delicate manner and it's disconnection was observed at the inlet of the microcatheter.Three attempts were made to change the system, however, all attempts were unsuccessful.The procedure was aborted for surgical time and rescheduled.The pipeline was not used for an indicated that is not approved (off-label).The pipeline and any accessory devices were prepared as indicated in the ifu.There were no patient symptoms or complications associated with this event.It was unknown if a dapt (dual antiplatelet treatment) was administered.The angiographic result post procedure was normal.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the ophthalmic segment of the internal carotid artery with a max diameter of 3.8mm and a 4.5mm neck diameter.It was noted the patient's vessel tortuosity was normal.

• Brand Name: MARKSMAN
• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 12778246
• Report Number: 2029214-2021-01432
• Device Sequence Number: 11627876
• Product Code: KRA
• UDI-Device Identifier: 00836462014077
• UDI-Public: 00836462014077
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K091559
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/09/2021

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: 05/26/2023
• Device Model Number: FA-55150-1030
• Device Catalogue Number: FA-55150-1030
• Device Lot Number: 220085280
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/09/2021
• Date Device Manufactured: 05/26/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Female