MAUDE Adverse Event Report: TERUMO MEDICAL CANADA, INC. 6MM X20MM AZUR DETACHABLE COIL; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Lot Number 2003035KG

Device Problems Fracture (1260); Unraveled Material (1664); Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 03/20/2021

Event Type  malfunction  

Event Description

Pt had an ir procedure: fluoroscopic abdominal arteriogram with coil embolization of the gastroduodenal artery and suspected anterior superior pancreaticoduodenal artery.There was a dysfunction of the cranial most detachable gastroduodenal embolization coil during deployment with resultant extension into the common hepatic artery.Multiple attempts to reposition the coil were made prior to attempted loop snare removal of the coil.However, during attempted removal, the embolization coil unraveled and fractured extending into the infrarenal abdominal aorta.Intraoperative consultation with vascular surgery was made, whom recommended that given the patient's underlying medical comorbidities and condition, further attempts at retrieval or repositioning of the embolization coil should be aborted.Cirrhosis of liver without ascites, alcohol abuse (chronic), alcohol dependence, acute blood loss anemia, hypokalemia, transaminitis, gastritis, duodenal ulcer, hypomagnesemia, hypoalbuminemia- every day smoker.

• Brand Name: 6MM X20MM AZUR DETACHABLE COIL
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): TERUMO MEDICAL CANADA, INC.
• MDR Report Key: 11738025
• MDR Text Key: 248080642
• Report Number: MW5101048
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 2003035KG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 87