MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD YTTRIUM-90 GLASS MICROSPHERES; MICROSPHERES RADIONUCLIDE

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Code Available (3191)

Event Date 03/29/2018

Event Type  malfunction  

Event Description

Y-90 microspheres being administered to treat a pt with hepatocellular carcinoma.After administration of the microspheres, it was determined that the pt did not receive the full intended dose resulting in misadministration of the therapy.Concern about this incident being a product defect.Hepatocellular carcinoma.Therapy start date: (b)(6) 2018, therapy end date: (b)(6) 2018.

• Brand Name: YTTRIUM-90 GLASS MICROSPHERES
• Type of Device: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD
• MDR Report Key: 7641152
• MDR Text Key: 112579178
• Report Number: MW5078086
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 82