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

Catalog Number MUS0130069X6

Device Problem Deflation Problem (1149)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician was using a moma ultra device in the treatment of a plaque lesion in the left proximal common carotid artery(cca).The device was prepped as per ifu with no issues identified.The proximal cca balloon would not completely deflate even with 50/50 saline contrast pep.A 60cc syringe of negative pressure was needed to deflate the balloon.There were no patient symptoms or complications associated with this event.

Manufacturer Narrative

The physician initially used a 5cc syringe, then tried the 30cc vaclock syringe finally used a 60cc syringe of negative pressure was needed to deflate the balloon the balloon did not fully deflate but could be removed through the sheath.The patient is reported to be doing fine.Device evaluation: the catheter was visually inspected; no abnormality was noted.The proximal and distal balloons were in post-inflation profile.A small amount of contrast/saline solution was noted in the proximal balloon chamber.A partially water filled 6cc syringe was attached to proximal balloon inflation lumen luer lock.A vacuum could be drawn and held.The proximal balloon was inflated using tap water and deflated several times to remove the residual contrast/saline solution.The 6cc water filled syringe was attached to the proximal balloon inflation lumen luer lock a vacuum was drawn and allowed to slowly return to neutral position to remove air from the inflation lumen and balloon.The proximal balloon was pressurized with the 6cc water filled syringe.A vacuum was pulled, and the tap water filled proximal balloon fully deflated within 13 seconds.Twenty milliliters of 50/50 glycerin and water solution was prepared to simulate the 50/50 contrast and saline mixture.The 6cc solution filled syringe was attached to the proximal balloon inflation lumen luer lock and the balloon was filled.A vacuum was pulled, and the tap water filled proximal balloon fully deflated within 28 seconds.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 US
• 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: 8649607
• MDR Text Key: 146358793
• Report Number: 3004066202-2019-00026
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08033477071909
• UDI-Public: 08033477071909
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2021
• Device Catalogue Number: MUS0130069X6
• Device Lot Number: 1L010758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 05/29/2019
• Supplement Dates Manufacturer Received: 05/29/2019
• Supplement Dates FDA Received: 06/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR