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

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body Reaction (1868)

Event Date 01/28/2013

Event Type  Injury  

Manufacturer Narrative

The microcatheter was not returned for analysis.The separated distal portion of the microcatheter remains within the patient.Attempts have been made to obtain additional information, however, our attempts have been unsuccessful.Based on the reported information, the report of catheter entrapment and separation could not be confirmed and the cause could not be determined.It is possible the separation resulted due to tensile failure of the microcatheter during extraction from the treatment site.It is likely that the microcatheter was pulled beyond the 20cm limit noted in the instructions for use.Per our device¿s, instructions for use (ifu): ¿if catheter entrapment is suspected (with any embolic agent), fast catheter retrieval technique may result in catheter shaft separation and potential vascular damage.Follow catheter retrieval instructions at the end of instructions for use.Do not apply more than 20 cm of traction to catheter to minimize risk of catheter separation.Mdr related to this event: 2029214-2017-00286 2029214-2017-00287.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

Citation: transarterial treatment with onyx of cognard type iv anterior cranial fossa dural arteriovenous fistulas.Li c1, wu z, yang x, li y, jiang c, he h.J neurointerv surg.2014 mar;6(2):115-20.Doi: 10.1136/neurintsurg-2012-010641.Epub 2013 feb 15.This patient presented with intraparenchymal hemorrhage was asymptomatic with sudden seizure, headache, nausea, without neurological impairment.The right middle meningeal artery was treated with the liquid embolic material.There was report of catheter entrapment.Fortunately, hemorrhage did not occur during retrieval of the microcatheter and there was no subsequent complication associated with retention of the distal part of the microcatheter in this case.Post intervention, the patient was reported to have transient chemosis and retro-orbital discomfort.However, this did not required medical intervention.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MARATHON
• 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 ; 9492753836
• MDR Report Key: 6445033
• MDR Text Key: 71201389
• Report Number: 2029214-2017-00286
• Device Sequence Number: 1
• Product Code: KRA
• 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,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2016
• 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
• Patient Outcome(s): Disability