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

Catalog Number MOM0130069X6

Device Problems Deflation Problem (1149); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/13/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: the device was returned in a plastic envelope.The information on the luer is consistent with the complaint.The inflation syringe provided for inflation was the 30 ml vaclock provided with the device.In the pre-decontamination a visual inspection was conducted: traces of blood were detected into the working channel and radio opaque solution were found into inflation lines.The purging procedure was executed successfully, no leak was detected.The proximal balloon tube appeared visually deformed, not completely adherent to the shaft.The proximal balloon was inflated (with a mixture 50/50 saline solution and contrast medium) till 9 mm and it appeared completely asymmetrical with respect to the shaft.The bonding of the proximal balloon tube were analyzed and they were found conformal to wi0141.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 (inflated to 5 mm), which correctly inflated and deflated.

Event Description

The physician was attempting to use one mo.Ma ultra device to treat a mildly calcified and mildly tortuous carotid artery lesion exhibiting 10% stenosis.The device was removed from its packaging and inspected with no issues noted.Negative prep was not performed.The lesion was predilated using a non-medtronic device (once at 8 atm for 30 seconds) leaving 30% residual stenosis.It was reported that no resistance was encountered when advancing the device to the target lesion.The moma device was advanced in the external carotid artery (eca) and common carotid artery (cca), and the eca balloon and cca balloon were dilated.After the procedure was completed the physician attempted multiple times to deflate the balloons with no success.The physician was forced to remove the balloons while inflated.The device was removed with no issues.Once removed from the patient, the physician attempted to squeeze the balloon, the balloon deflated.No patient injury was reported.

• Brand Name: MO.MA ULTRA
• Type of Device: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer (Section G): INVATEC SPA; via martiri della liberta, 7; roncadelle 25030 ; IT 25030
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6948241
• MDR Text Key: 90307814
• Report Number: 3004066202-2017-00105
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2019
• Device Catalogue Number: MOM0130069X6
• Device Lot Number: 1H023794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 89 YR