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

Catalog Number MOM0130069X6

Device Problems Burst Container or Vessel (1074); Material Puncture/Hole (1504)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/30/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician used a moma ultra during treatment of the patient¿s internal carotid artery, lesion was reported to have no tortuosity or calcification.It is reported there was a little hole observed in the proximal balloon.No patient injury reported.

Manufacturer Narrative

Additional information: the momma was being used to treat the patient's common carotid artery.Ifu was followed and the device was prepped without issue.No resistance was encountered when advancing the device.The hole was observed while the physician was inflating the balloon.The device was removed from the patient without issue.A spider fx embolic protection device was then used to complete the procedure.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: the device was returned for evaluation.On initial visual inspection no visible issue was noted.Evidence of radiopaque liquid in the inflation lumens was found.During the analysis negative pressure was applied with a syringe on the proximal balloon and on the distal one, but it was not possible to inflate the balloons due to the radiopaque solution in the inflation lumens.The proximal balloon was found deformed.Further test could not be conducted due to the condition of the returned device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MO.MA ULTRA
• Type of Device: CATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
• Manufacturer (Section D): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana, b.c. 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana, b.c. 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7762845
• MDR Text Key: 116872596
• Report Number: 9612164-2018-01988
• Device Sequence Number: 1
• Product Code: NTE
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup,Followup,Followup
• Report Date: 11/22/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2019
• Device Catalogue Number: MOM0130069X6
• Device Lot Number: 1I010123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 08/09/2018; 08/08/2018; 10/26/2018
• Supplement Dates FDA Received: 08/29/2018; 10/02/2018; 11/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2017
• 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: 75 YR