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

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

The microcatheters was not returned for analysis.Based on the reported information, the report of entrapment could not be confirmed.Attempts have been made to obtain specific information have been made, however, our attempts have been unsuccessful.There is no evidence suggesting that the microcatheter was defective.In these events, excessive reflux and the patient¿s anatomy likely contributed to the reported event.Per the liquid embolic material instructions for use (ifu): do not allow more than 1 cm of liquid embolic material to reflux back over catheter tip.Angioarchitecture, vasospasm, excessive liquid embolic material reflux, or prolonged injection time may result in difficult catheter removal and catheter 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 is unknown, but could potentially include clot formation, infection or catheter migration.Linked events: 2029214-2017-00960 2029214-2017-00961.

Event Description

Citation: ¿successful transvenous embolization of brain arteriovenous malformations using onyx in five consecutive patients¿ iruena kessler, md, phd.Roberto riva, md.Maria ruggiero, md.Monica manisor, md.Maher al-khawaldeh, md.Charbel mounayer, md, phd.Medtronic received the following reports: patient 1: a (b)(6) man presented with cerebral hemorrhage.The bavm was completely occluded, but the microcatheter was left in place and not removed from the treating vessel.Postoperatively, the patient was unchanged and could perform his daily life activities normally (mrs score = 0).Follow-up angiography at 6 months showed complete obliteration of the bavm.Patient 2: a (b)(6) young woman presented with left hemiparesis associated with headache.The nidus was partially occluded, but the microcatheter was left in place.Postoperatively, the patient was clinically unchanged (mrs score = 2) and was discharged.The patient was sent to a gk radiosurgery service for adjunctive treatment, and a follow.

• Brand Name: ECHELON
• 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: trciha miles ; 9775 toledo way; irvine, CA 92618 ; 9492753836
• MDR Report Key: 6787673
• MDR Text Key: 82468989
• Report Number: 2029214-2017-00961
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2017

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
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 08/11/2017
• 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
• Patient Outcome(s): Disability