MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION AZUR; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number 45-480310

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2014

Event Type  malfunction  

Event Description

Doctor was using an azur detachable coil and the coil detached from the pusher wire by itself in the microcatheter.The doctor then pulled the whole system out and did not deploy the coil in the patient.There was no harm to the patient or complications.

• Brand Name: AZUR
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 4486613
• MDR Text Key: 15898467
• Report Number: 4486613
• Device Sequence Number: 1
• Product Code: HCG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/09/2014

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: Physician
• Device Catalogue Number: 45-480310
• Device Lot Number: 140522L8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/09/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/09/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES
• Patient Age: 57 YR