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	11/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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
Physician was attempting to treat a moderately calcified lesion in the right cca using moma ultra occluding device.It was reported that the carotid stenting procedure completed with aspiration x 3 checked for debris none noted.Eca balloon deflated 60 seconds, then waited for cca balloon to deflate, cca balloon does not deflate sales rep asked physician to put retracted pressure on catheter and cca balloon deflates down to 2-3mm moma then retracted out of eca angiography of carotid and cerebral arteries obtained.Vessels are patent and no adverse event noted within the cca moma then remove through 9fr sheath possibly kinked during procedure was not able to determine any kink under angiography physician requested moma be evaluated on why balloon did not completely deflate.Procedure was completed and no injury occurred to patient and patient was discharged home with no complications.
Additional Manufacturer Narrative
Device evaluation: a visual inspection was conducted and a kink was found on the shaft, close to the hub (not preventing the inflation/deflation of the balloon).The purging procedure was executed successfully, no leak was detected.The proximal balloon tube appeared visually deformed, not completely adherent to the shaft.Once the balloon was inflated (with a mixture 50/50 saline solution and contrast medium) it appeared completely asymmetrical with respect to the shaft.The bonding of the proximal balloon tube was analysed and they were found to be within specifications.The inflation occurred in the opposite side of the exit of the inflation tube.It was not possible to completely deflate the balloon since, once the balloon tube came in contact with the exit of inflation lumen, it prevented the deflation of the asymmetrical part of the balloon (still partially inflated).No abnormalities noted on the distal balloon, which correctly inflated and deflated.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.
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: 6141283
• Report Number: 3004066202-2016-00298
• Device Sequence Number: 357961
• Product Code: NTE
• UDI-Device Identifier: 08033477050140
• UDI-Public: 08033477050140
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2016

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: 10/22/2017
• Device Catalogue Number: MUS0130069X6
• Device Lot Number: 1G022604
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Initial Date Received by Manufacturer: 11/03/2016
• Supplement Date Received by Manufacturer: Not provided; 12/06/2016
• Initial Report FDA Received Date: 12/02/2016
• Supplement Report FDA Received Date: 01/04/2017; 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 75