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

Catalog Number	MUS0130069X6
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a mo.Ma.Ultra device during the treatment of a >90% stenosed moderately calcified soft tissue lesion in the mid common carotid artery.Abnormalities reported in relation to patient anatomy are type 2 arch, ica lesion, eca branches.The device was inspected and prepped as per ifu without issue.A 50:50 inflation contrast: saline was used.It is reported the cca balloon would not deflate.Multiple attempts were made, and the physician attempted to put a wire through the balloon port to loosen the valve in order to release the contrast but the wire would not pass through the valve.The patient was embolically protected as several strain filters were filled with debris until cleared.The balloon had to be removed inflated.The patient post procedural neurological test was performed, and the patient passed all tests showing he was stable.It was reported that the patient is doing well with no adverse events following the procedure.
Additional Manufacturer Narrative
Event description - additional information it was reported that the use of a t-safety valve was recommended at the start of the procedure but was not used by the physician.The balloon had to be removed inflated against ifu indications.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MO.MA ULTRA US
• Common Device Name: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• MDR Report Key: 7517652
• Report Number: 3004066202-2018-00022
• Device Sequence Number: 1164619
• Product Code: NTE
• UDI-Device Identifier: 08033477050140
• UDI-Public: 08033477050140
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K092177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2019
• Device Catalogue Number: MUS0130069X6
• Device Lot Number: 1I012818
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 90