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

Catalog Number MOM0130069X6

Device Problem Deflation Problem (1149)

Patient Problems Stroke/CVA (1770); Convulsion, Tonic (2223); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/21/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician intended to use moma ultra cerebral protection device during treatment of the patient¿s common carotid artery.It is reported issues were experienced when trying the deflate the proximal cca balloon.The proximal balloon could not be deflated, and the physician removed the moma system with the balloon still inflated.He deflation of the balloon occurred when the moma system passed through the introducer sheath.The patient did not tolerate the clamping and experienced convulsions.The patient is reported to be fine.No further injury reported.

Manufacturer Narrative

Additional information: the lesion was located in the left internal carotid artery presenting 80% stenosis.The balloon was inflated in the common carotid artery.Ifu was followed.The vessel was pre and post dilated.There was no need for surgery or similar to remove the balloon from the patient.No additional treatment was needed to manage the convulsion.There was no vessel damage.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.

Manufacturer Narrative

Product analysis: the mo.Ma proximal ultra cerebral protection device was received within its shelf carton, within its protective transportation tray and tube.Returned were the mo.Ma y-piece with hemostatic valve, 3-way stopcock, 2 1-way stopcocks, and a t-safety connector from the mo.Ma kit.The information printed on the manifold is consistent for mo.Ma lot: 1n001469.A visual examination of the returned mo.Ma revealed that the balloon were in a post-inflation profile.A water filled syringe was attached to the proximal inflation lumen luer lock (cca) of the manifold and the proximal balloon could be inflated and deflated.A water filled syringe was attached to the distal inflation lumen luer lock (eca) of the manifold and the distal balloon could not be inflated.No leaks nor kinks were noted in the mo.Ma device during the attempted inflation.The most likely reason the distal balloon could not be inflated is that the distal inflation lumen pathway is obstructed with dried contrast solution from the procedure.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.

• 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: 10592620
• MDR Text Key: 208738910
• Report Number: 3004066202-2020-00028
• 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,Followup
• Report Date: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2022
• Device Catalogue Number: MOM0130069X6
• Device Lot Number: 1N001469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR