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

Catalog Number MOM0130069X6

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the physician intended to use moma balloon at the common carotid artery.The device was prepped without issue.When the distal balloon was inflated, contrast was still observed at the external carotid artery(eca).The physician repositioned the balloon closer to the bifurcation however, after inflation of the proximal balloon, the contrast was seen flowing through the internal carotid artery(ica).The physician decided to remove the moma device and replace it with a non-medtronic protection device.There was no patient injury reported.

Manufacturer Narrative

Additional information: treatment was being carried out in the mid right artery.Vessel diameter reported as 6mm.Lesion described as being 40mm, calcified and fibrous.No tortuosity reported.Moderate calcification reported.Lesion exhibited 70% stenosis.The balloon did not block the eca along the entire artery.The cca was correctly blocked.No intervention was required, the device was safely removed from the patient.The procedure was completed successfully without injury.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.

Manufacturer Narrative

Image review three photographic images of cine images were provided for evaluation.In image 1 the distal balloon is inflated in the external carotid artery, a guidewire is protruding distally from the balloon, and the proximal balloon is not inflated within the common carotid artery.There is no radiopaque contrast visible distal of the inflated distal balloon.Radiopaque contrast is visible within the internal carotid artery.In image 2 the distal balloon is inflated in the external carotid artery, a guidewire protrudes further distally from the distal balloon, and no radiopaque contrast is visible distal of the distal balloon.The proximal balloon is inflated in the common carotid artery.Radiopaque contrast is visible within the internal carotid artery.In image 3 the distal balloon is inflated in the external carotid artery, no guidewire protrudes from the distal balloon, and radiopaque contrast is visible distal of the distal balloon.The proximal balloon is not inflated in the common carotid artery.Radiopaque contrast is visible within the internal carotid artery.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: 8767694
• MDR Text Key: 150293435
• Report Number: 3004066202-2019-00030
• 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: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/24/2020
• Device Catalogue Number: MOM0130069X6
• Device Lot Number: 1L003695
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 62