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

Model Number MOM0130068X5

Device Problems Device Expiration Issue (1216); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to use the 8f mo.Ma ultra cerebral protection device with the protégé rx carotid stent to treat a lesion in the common carotid artery.The lot number provided for the mo.Ma ultra used during the procedure confirmed that the mo.Ma was 7months expired at the time of the procedure.It was reported the physician encountered difficulty in advancing the protégé rx through the mo.Ma ultra, the facility used the protégé rx with a crossing profile of the 0.0078 with a mo.Ma ultra 8f with an internal diameter 0.0068¿¿ by mistake.The facility was made aware of the error, another mo.Ma protection device was used to complete the procedure.The procedure was successful with no injury to the patient 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: 7292210
• MDR Text Key: 100837086
• Report Number: 3004066202-2018-00007
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: MK
• 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: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2017
• Device Model Number: MOM0130068X5
• Device Lot Number: 1G012684
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2018
• Date Device Manufactured: 06/08/2015
• 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: 76 YR
• Patient Weight: 85