MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 ECHELON; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-ECHELON

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Date 05/14/2021

Event Type  Injury  

Event Description

Ökçesiz, i., dönmez, h., vural, a., karabiyik, ö., yüce, i., çagli, s.(2021).The role of ct angiography and endovascular treatment in acute-massive head and neck bleeding.European archives of oto-rhino-laryngology, 279(2), 875¿882.Https://doi.Org/10.10 07/s00405-021-06813-6.Summary: to report the results of the endovascular treatment of acute-massive head and neck bleeding in a single center and underline the value of computerized tomography-angiography and endovascular treatment of this desperate patient group.Identified events: 1.5 patients had pseudoaneurysm formations demonstrated on a ct scan, one of which was an active extravasation.

Manufacturer Narrative

Ökçesiz, i., dönmez, h., vural, a., karabiyik, ö., yüce, i., <(>&<)> çagli, s.(2021).The role of ct angiography and endovascular treatment in acute-massive head and neck bleeding.European archives of oto-rhino-laryngology, 279(2), 875¿882.Https://doi.Org/10.10 07/s00405-021-06813-6.This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.Associated regulatory report: 2029214-2022-00387.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ECHELON
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 13723612
• MDR Text Key: 288378656
• Report Number: 2029214-2022-00388
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-ECHELON
• Device Catalogue Number: UNK-NV-ECHELON
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/03/2022
• 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): Other
• Patient Age: 56 YR
• Patient Sex: Male