MAUDE Adverse Event Report: COVIDIEN (IRVINE) MARATHON MICROCATHETER; CATHETER, CONTINUOUS FLUSH

Model Number UNKNOWN

Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2015

Event Type  malfunction  

Manufacturer Narrative

Interventional neuroradiology, douglas m choo et.Al onyx versus nbca and coils in the treatment of intracranial dural arteriovenous fistulas" twenty-four patients (17 males; age 1.67¿84 years, m=56 ±17.7 years) the device was not returned for analysis; therefore, no definitive conclusion can be drawn regarding the clinical observation.Additional information has been requested from the author of this article regarding this case.Should it become available a supplemental report will be submitted.The patient was treated with onyx 18 or onyx 34.Related mdrs to this article: 2029214-2017-00783 2029214-2017-00784 2029214-2017-00785.

Event Description

Medtronic received information through literature review that the marathon catheter ruptured and was retained in one patient during treatment of intracranial dural arteriovenous fistulas (davf).A total of 24 patients with davfs were treated with endovascular embolization during this time.Onyx was used in 12 cases, 9 were treated with only nbca, and 3 were treated with only coils.Hemorrhage was the most frequent presenting symptom ((b)(6), 30%), followed by headache ((b)(6), 21%).

• Brand Name: MARATHON MICROCATHETER
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• Manufacturer Contact: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 9498373700
• MDR Report Key: 6645894
• MDR Text Key: 77729804
• Report Number: 2029214-2017-00784
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2017

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
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: No
• 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