MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE; SINGLE USE IMPLANTABLE MEDICAL DEVICE

Device Problems Improper or Incorrect Procedure or Method (2017); Inaccurate Delivery (2339)

Patient Problem Radiation Exposure, Unintended (3164)

Event Type  No Answer Provided  

Event Description

Delivered a dose to the right lobe instead of the intended left lobe [device deployment issue] case description: initial information received on 28-jul-2016: this spontaneous medical device report was received from a physician via a company representative and concerned a patient of unknown age and gender.The patient's medical history and concomitant medication were not provided.On an unspecified date the patient received therasphere (dose, indication, lot number and expiration date not reported).On an unspecified date the treating physicians had done a two month pet scan and confirmed that they delivered a dose to the right lobe instead of the left lobe.There was no patient impact at the time of the report.The outcome of the event was unknown.No other information available.Follow-up information is expected.The reporting physician did not assess the severity or the causality of the event.The company considers the event as serious (medically significant).Case comment: device deployment issue is considered unlisted according to the therasphere current reference safety information.Delivered a dose to the right lobe instead of the left lobe is not assessable as an event.This single case report does not modify the risk benefit balance of therasphere.The company is continuously monitoring all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.

Event Description

Delivered a dose to the right lobe instead of the intended left lobe [device deployment issue].Case description: initial information received on 28-jul-2016: this spontaneous medical device report was received from a physician via a company representative and concerned a patient of unknown age and gender.The patient's medical history and concomitant medication were not provided.On an unspecified date the patient received therasphere (dose, indication, lot number and expiration date not reported) on an unspecified date the treating physicians had done a two month pet scan and confirmed that they delivered a dose to the right lobe instead of the left lobe.There was no patient impact at the time of the report.The outcome of the event was unknown.No other information available.Follow-up information is expected.The reporting physician did not assess the severity or the causality of the event.The company considers the event as serious (medically significant).Follow-up information received on 11-aug-2016: the company representative reported that this incident was already reported on 24-may-2016.According to this new information, this case is a duplicate of (b)(4), all information was already included in (b)(4).This duplicate case will be therefore nullified.Case comment: device deployment issue is considered unlisted according to the therasphere current reference safety information.Delivered a dose to the right lobe instead of the left lobe is not assessable as an event.This single case report does not modify the risk benefit balance of therasphere.The company is continuously monitoring all respective reports received and, based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.

• Brand Name: THERASPHERE
• Type of Device: SINGLE USE IMPLANTABLE MEDICAL DEVICE
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; farnham, surrey ; UK
• Manufacturer (Section G): BIOCOMPATIBLES UK LTD; farnham business park; weydon lane; farnham, surrey GU9 8 QL; UK GU9 8QL
• Manufacturer Contact: 11 hines road, suite 200; ottawa, ontario K2K 2-X1
• MDR Report Key: 5855940
• MDR Text Key: 51446432
• Report Number: 3002124545-2016-00058
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2016
• 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): Other