MAUDE Adverse Event Report: INVATEC SPA MO.MA ULTRA; CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE

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

Patient Problems Bradycardia (1751); Occlusion (1984); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic conducted a post market clinical follow-up (pmcf) survey to seek out potential new risks and assess the performance of medtronic¿s mo.Ma ultra¿ proximal cerebral protection device (mono-occlusion balloon system and double-occlusion balloon system).Survey results received for an interventional cardiologist with 21 years¿ experience who was been using the mo.Ma ultra¿ proximal cerebral protection device system (mono-occlusion balloon system and double-occlusion balloon system) since 2019.The respondent used mo.Ma ultra¿ proximal cerebral protection device (mono-occlusion balloon system and double-occlusion balloon system) 150 devices since practicing, and 120 in the last 12 months.The respondent used mo.Ma ultra¿ proximal cerebral protection device (double-occlusion balloon system) system since 2016.The respondent used mo.Ma ultra¿ proximal cerebral protection device (mono-occlusion balloon system and double-occlusion balloon system) 40 devices since practicing, and 10 in the last 12 months.For mo.Ma ultra¿ proximal cerebral protection device (mono-occlusion balloon system), it was reported that the respondent experienced 5 carotid artery spasm events deemed somewhat concerning and 2 of these were related to the device itself.For mo.Ma ultra¿ proximal cerebral protection device (double-occlusion balloon system), it was reported that the respondent experienced 4 carotid artery spasm events which were deemed somewhat concerning and 2 of these were deemed related to device.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MO.MA ULTRA
• Type of Device: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• MDR Report Key: 9744286
• MDR Text Key: 192644970
• Report Number: 3004066202-2020-00006
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• PMA/PMN Number: K092177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1