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

Device Problem Difficult to Remove (1528)

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

Event Date 08/24/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.Per the marathon¿s instructions for use (ifu): precautions - if catheter entrapment is suspected (with any embolic agent), fast catheter retrieval technique may result in catheter shaft separation and potential vascular damage.Slowly remove any ¿slack¿ in the distal catheter shaft.Gently and slowly apply 3-5 cm traction to the catheter to begin catheter retrieval.Should catheter removal become difficult, the following will assist in catheter retrieval.Assess the following parameters by observing the distal shaft of the catheter: vessel straightening, traction on embolic cast, catheter tip releasing from embolic cast.Further traction (of 3-5 cm) may be applied gently if necessary to transfer distal catheter shaft.Hold this traction for a few seconds and release.Assess traction of vasculature to minimize risk of hemorrhage.This process can be repeated intermittently until catheter is retrieved.Note: do not apply more than 20 cm of traction to catheter to minimize risk of catheter separation.Under some difficult clinical situations, it may be safer to leave a flow-directed catheter in the vascular system rather than risk rupturing the malformation and, consequently a hemorrhage, by exercising too much traction on an entrapped catheter.This is accomplished by stretching the catheter and cutting the shaft near the entry point of vascular access allowing the catheter to remain in the artery.If catheter breaks during removal, distal migration or coiling of the catheter may occur.Same day surgical resection should be considered to minimize risk of thrombosis.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: ¿snaring of a glued microcatheter during embolization of an arteriovenous malformation with n-butyl cyanoacrylate,¿ rasmus h.Dahl, markus holtmannspötter, henrik gutte et.Al.Medtronic received information through literature review that marathon catheter was entrapped during arteriovenous malformation (avm) treatment with nbca glue.It was reported that marathon microcatheter was navigated distally to embolize a posterior nidus compartment using acrylic glue.During this injection, reflux occurred earlier than expected, before relevant nidus penetration and glued the catheter tip rapidly into the distal feeder.Immediate attempts to carefully withdraw the microcatheter by simple pulling of its proximal end failed.Leaving the microcatheter in the acha was considered to "expos" the patient to a significant risk of thromboembolic complications in a sensitive territory, endovascular catheter removal was discussed then performed.First, a buddy-catheter technique 10 using a second microcatheter (headway duo, microvention) that was advanced in parallel to the marathon into the distal acha, and was attempted but failed to free the glued microcatheter.Therefore, the hub of the marathon microcatheter was cut off allowing for removal of the sofia 55 catheter.Then, a 2-mm amplatz goose-neck micro snare (medtronic) was slid over the end of the entrapped microcatheter and slowly advanced along this catheter to its distal end.This was supported by slightly pulling back the entrapped marathon to straighten the course of the acha.The snare was then tightened around the catheter¿s tip as closely as possible to the nbca cast.Repeated, gentle, and simultaneous pulling of both the trapped microcatheter and the snare was applied over approximately 10 minutes.Whereas it appeared not possible to grab the glue surrounding the catheter itself to break it off, repeated alternate pulling and relaxing the system eventually resulted in freeing and removal of the microcatheter.Immediate post procedure digital subtraction angiography run showed no noticeable spasm, dissection, or extravasation.The patient woke up with no new deficits and had an uneventful postoperative course.

• 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: 8108302
• MDR Text Key: 128568644
• Report Number: 2029214-2018-00975
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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
• Report Date: 11/27/2018

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2018
• Initial Date FDA Received: 11/27/2018
• 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): Required Intervention
• Patient Age: 26 YR