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

Catalog Number MOM0130069X6

Device Problems Burst Container or Vessel (1074); Fracture (1260); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician intended to use mo.Ma ultra cerebral protection device during treatment of a plaque lesion in the patient¿s proximal common carotid artery.Moderate vessel calcification and tortuosity are reported.Lesion exhibited 90% stenosis.The device was inspected without issue prior to use.There was no damage noted to the device packaging.Ifu was followed.It is reported during prep of the device, a break occurred.It is reported the external carotid balloon could not be opened.The physician attempted to use a syringe but observed contrast leaking as the balloon had burst during the procedure.The device was introduced into the patient's vasculature.No patient injury was reported.

Manufacturer Narrative

Image review: a single photographic image was received for technical analysis.The image is of the mo.Ma.Manifold and distal end of the catheter.Sanguine residue is visible on the manifold and catheter.The one-way stopcocks are attached to the balloon inflation /deflation ports.The t-safety connector does not appear in the image attached to either of the one-stopcocks attached to the balloon inflation/deflation ports.The distal balloon (external carotid artery) appears to be fully deflated.Due to the quality and clarity of the image it is not possible to determine if there is a pinhole leak or tear in the compliant balloon chamber material.The catheter appears to be kinked just distal of the manifold.In the background of the image is the 0.035¿ guide wire compatible hollow mandrel with a 0.035¿ guide wire protruding from its distal end.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: 10046092
• MDR Text Key: 190640703
• Report Number: 3004066202-2020-00017
• 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: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2021
• Device Catalogue Number: MOM0130069X6
• Device Lot Number: 1M005651
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1