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

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Sepsis (2067)

Event Type  Injury  

Manufacturer Narrative

Limited information was reported.There was no device malfunction reported.Within a few days of treatment, the tumor became an abscess causing sepsis which required medical intervention.The abscess was drained and it was reported that the drainage was radioactive.Abscess and sepsis are anticipated events associated with the use of therasphere.Based on the limited information reported, a relationship between the events reported and the therasphere could not be determined.The release of the requested information is pending the approval of the hospital's compliance officers in accordance with the hospital's legal guidelines as this patient was enrolled in a study.If additional information is reported, a follow up report will be submitted.

Event Description

On 16 oct 2018, it was reported that a male patient was treated with therasphere for a large metastasis from pancreatic adenocarcinoma a few weeks prior (treatment date not reported).Within a few days of treatment, the tumor became an abscess causing sepsis which required draining.The necrotic material and pus was reported to be very "hot" and had to be disposed of under the supervision of radiation safety.Follow up information was requested, but to date, no additional information has been received.

• Brand Name: THERASPHERE
• Type of Device: YTTRIUM-90 GLASS MICROSPHERES
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; farnham business park; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer (Section G): BIOCOMPATIBLES UK LTD; farnham business park; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: sandra bausback ; 300 four falls corp cntr - 380; 300 conshohocken st. rd.; west conshohocken,, PA 19428-2998 ; 6103311537
• MDR Report Key: 8070916
• MDR Text Key: 127143112
• Report Number: 3002124543-2018-00051
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2018
• Initial Date FDA Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Required Intervention