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	06/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician used a mo.Ma ultra device during treatment of a 80% stenosed calcified lesion in the patients proximal left common carotid artery.Moderate calcification and tortuosity were reported.The ifu was followed and the device was prepped without issue.A 50/50 contrast/saline was used to inflate the balloon.It is reported the cca balloon would not deflate via port during procedure to move the mo.Ma to a more occlusive position.Attempts were made with multiple syringes to deflate but didn¿t work.It was observed that the stump pressure remained wedge shaped.The physician wired the ic lesion and deployed a 6mm spider fx.The ic lesion was pre-dilated with a 3mm rapidcross balloon and a 10/7 protege rx was deployed across the lesion.Post-dilation was performed with a 4.5 x 15 coronary balloon.Stump pressure was equal to groin 9fr sheath pressure and under fluoroscopy it was observed the common balloon had deflated on its own.The physician proceeded with post angiography and was comfortable that the case was completed.The devices were removed and no patient injury reported.
Additional Manufacturer Narrative
Additional information: the t-safety valve was not used the device was returned for evaluation.After the successful advancement of the 0.035¿ guidewire through the device purging was performed but failed.An attempt was made to inflate the proximal balloon.It was possible to inflate the balloon but the pressure could not be maintained.A leakage from the inflating port was detected and a crack was clearly visible on the port.An attempt was made to deflate the balloon but air was sucked from the port preventing balloon deflation.No other issues were detected.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7657709
• Report Number: 3004066202-2018-00037
• Device Sequence Number: 18865718
• Product Code: NTE
• UDI-Device Identifier: 08033477050140
• UDI-Public: 08033477050140
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 10/05/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/22/2019
• Device Catalogue Number: MUS0130069X6
• Device Lot Number: 1I013152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2018
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 07/17/2018; 08/08/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 07/19/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 90