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

Model Number 105-5056

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

Patient Problems Intracranial Hemorrhage (1891); Foreign Body In Patient (2687)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

The device was not returned for analysis.Based on the reported information, the report of catheter separation due to onyx entrapment could not be confirmed.Separation can occur if the marathon micro catheter is pulled beyond the 20cm limit noted in the instructions for use (ifu).It is likely the reported entrapment of the marathon micro catheter contributed to the separation issue.Entrapment can be caused by angioarchitecture, vasospasm, reflux or injection time.It is possible the patient¿s ¿severe and small in diameter¿ anatomy may have contributed to the event; however, the cause for the entrapment could not be determined at this time.Per the marathon 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.Do not apply more than 20 cm of traction to catheter to minimize risk of catheter separation.¿ per the onyx les ifu: warnings: ¿do not allow more than 1 cm of the onyx les to reflux back over catheter tip.Angioarchitecture, vasospasm, excessive onyx les reflux, or prolonged injection time may result in difficult catheter removal and potential entrapment.Excessive force to remove an entrapped catheter may cause serious intracranial hemorrhage.The long-term effects of an entrapped catheter that is left in a patient are unknown, but potentially could include clot formation, infection, or catheter migration.¿ if information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that during treatment of an arteriovenous malformation (avm), with admitting feeder from left superior cerebellar artery (sca) due to bleeding episode.The marathon catheter was reported to have been entrapped within in the onyx cast.During the attempted removal, the marathon was reported to have separated allowing the onyx to embed into an unintended location, because of the manipulations to remove the marathon catheter a hemorrhage was also noted to have occurred.There was also report that the gooseneck snare broken, when it was pulled with force.The patient anatomy was severe and small in diameter.After performing the embolization at the branch of sca with onyx according to the 1st session, another feeder's embolization was planned, 7f road master 90cm and 4.2f fubuki were used as dac.The marathon was delivered to the target site.The basilar artery (ba) to superior cerebellar artery (sca) was tortuous.Onyx 18 was delivered and a backward flow of onyx onto the catheter from about 10 mm, with plugs and push technique, at the vicinity of nidus, embolization was performed with about 0.15 mm length of onyx.The embolization started at 15:30 and finished around 15:50.However, it was difficult to remove the catheter.Under 7f road master, the catheter was attempted to be removed with the aid of the dac.The dac was delivered to the vicinity of the onyx cast.Although the cast of onyx was pulled, the catheter was not removed.The hub of the marathon was cut, the fubuki of the dac was removed, and the catheter was attempted to be removed with a rebar 18 and gooseneck snare 4 mm.During this removal attempt, the marathon was believed to have torn allowing the onyx which remained in the marathon to scattered into peripheral pca.An onyx mass was recognized near p3 to p4, and it seemed to be embolizing two branches (symptoms unknown due to general anesthesia).After the 5f's guiding was from the inguinal side of the opposite side, "scepeter" 4 × 11 was delivered to ba via right va and tried to be removed the onyx with snare on the same side while suppressing vessel shift with balloon.Although the cast was pulled enough, it was not be removed.The gooseneck snare that was used broke near left va-pica.When the catheter was pulled to remove the marathon, bleeding occurred at the beginning of the left sca's branch, so to stop the bleeding with protamine was administered and the scepter balloon was used.The operation was stopped for 10 minutes.Hemostasis was performed and no increase in bleeding was observed.Judging that removal of the catheter was difficult, leaving lvis 4.5 × 23 from headway 21 to the vicinity of where the gooseneck snare loop (pica proximal), and the snare was pressed against the blood vessel wall, the procedure was completed.The marathon catheter was placed under the groin area skin and the procedure was completed.The surgical time was extended by more than 30 min.

• 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: 8095078
• MDR Text Key: 128063931
• Report Number: 2029214-2018-00964
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/21/2018

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
• Device Expiration Date: 03/26/2021
• Device Model Number: 105-5056
• Device Catalogue Number: 105-5056
• Device Lot Number: A621175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2018
• Initial Date FDA Received: 11/21/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2018
• 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; Disability
• Patient Age: 69 YR