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

Catalog Number MUS0130069X6

Device Problems Burst Container or Vessel (1074); Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician used a moma ultra with a non-medtronic 6fr sheath and a 0.035 non-medtronic guidewire during treatment of a 30 mm lesion in the patient¿s mid right common carotid artery of diameter 8 mm.The ifu was followed and the device was prepped and inflated during prep without issue.It is reported when the common balloon was inflated prior to stenting it burst.The balloon burst when the physician inflated with 8 cc of the contrast/saline mixture per the ifu.No component embolisation occurred.A new moma device was used to successfully complete the procedure.No patient injury was reported.

Manufacturer Narrative

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: 7717421
• MDR Text Key: 115110065
• Report Number: 3004066202-2018-00041
• Device Sequence Number: 1
• Product Code: NTE
• UDI-Device Identifier: 08033477050140
• UDI-Public: 08033477050140
• 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: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: MUS0130069X6
• Device Lot Number: 1L000677
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2018
• Initial Date FDA Received: 07/25/2018
• Supplement Dates Manufacturer Received: 08/08/2018
• Supplement Dates FDA Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1