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

Model Number 105-5055

Device Problem Difficult to Remove (1528)

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

Event Date 11/03/2014

Event Type  malfunction  

Manufacturer Narrative

The device has not been received.Attempts have been made to obtain additional information, however, our attempts have been unsuccessful.Based on the reported information, the report of catheter entrapment/difficult removal and onyx cast separation/movement could not be confirmed, and the root causes could not be determined.It is not known the duration between the onyx les injection and catheter retrieval.It is possible the catheter entrapment/difficult removal issue contributed to the onyx cast separation/movement¿ issue.Difficult catheter removal or catheter entrapment may be caused by long catheterization time, angio-architecture, vasospasm, reflux or injection time.Attempts have been made to obtain additional information, however, our attempts have been unsuccessful.The complaint investigation does not indicate a potential or confirmed manufacturing issue.Per the onyx instructions for use (ifu): ¿difficult catheter removal or catheter entrapment may be caused by one or more of the following factors: long catheterization time; angio-architecture: very distal arteriovenous malformation fed by afferent, lengthened, small, or tortuous pedicles; vasospasm; reflux; injection time¿ in addition, ¿upon completion of onyx¿ les injection, wait a few seconds, slightly aspirate syringe, and then gently pull the catheter to separate the onyx¿ les cast.Failure to wait a few seconds to retrieve micro catheter after onyx¿ les injection may result in fragmentation of onyx¿ les into non-target vessels.¿ all devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.Linked mdr¿s 2029214-2018-00266.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that during the onyx embolization, upon removal, a fragment of onyx detached, blocking the end of the catheter just before the collateral branch of the main arterial feeder of the arteriovenous malformation (avm).No patient injury was reported to have occurred.

• 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: 7631462
• MDR Text Key: 112285799
• Report Number: 2029214-2018-00576
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K093750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2018

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 Expiration Date: 01/16/2017
• Device Model Number: 105-5055
• Device Lot Number: 9864615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/04/2014
• 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 Age: 54 YR