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	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
The physician was attempting to use one moma ultra device to treat a lesion located in the left distal relatively straight lca.The device was removed from its packaging and inspected with no issues noted.The ifu was followed.After the physician deployed a stent successfully, the common carotid balloon was slow deflating.The t-safety was not used as the balloon was inflated under direct visualization.The physician pulled the balloon back while partially inflated into the arch of the vessel where the balloon was able to deflate fully.The balloon saline was originally mixed 1 : 3 but they could not visualize the balloon so this was changed to a 1 : 2 mixture.No patient injury was reported.

• 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: 6799187
• Report Number: 3004066202-2017-00092
• Device Sequence Number: 19083339
• Product Code: NTE
• UDI-Device Identifier: 08033477050140
• UDI-Public: 08033477050140
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 07/18/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/25/2018
• Device Catalogue Number: MUS0130069X6
• Device Lot Number: 1H021262
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 08/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1