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

Catalog Number MOM0130069X6

Device Problems Device Dislodged or Dislocated (2923); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician intended to use a moma ultra device during treatment.Ifu was followed and the device was prepped without issue.It is reported that resistance was experienced when inserting the 0.035¿ guidewire inside the moma prior to inserting into the patient and also during the first phase of the delivering of the system inside the patient.Under fluoroscopy, at the level of the aorta, it was observed that the eca marker and the cca markers were close.The device was removed from the patient due to this issue.On removal, a cut in the plastic channel below the eca marker was observed.The device was replaced with another moma ultra.No patient injury reported.

Manufacturer Narrative

A kink in the plastic channel between the two channels was observed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: the device was returned within a shipping box.The device was enveloped in a plastic pouch, inside a paper pouch.The information reported on the hub was consistent with the data in the complaint form received (lot# 1l000867).A tactile and visual inspection was been conducted: traces of dried blood was found on the device.The shaft was damaged and cut in the distal part.Additional information: the vessel was not particularly tortuous.No images are available.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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: 8141076
• MDR Text Key: 129616415
• Report Number: 3004066202-2018-00058
• 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: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MOM0130069X6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Date Manufacturer Received: 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR