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

Device Problems Therapy Delivered to Incorrect Body Area (1508); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2015

Event Type  No Answer Provided  

Event Description

Delivered a therasphere dose to the patient's gallbladder [device use error] case description: initial information received on (b)(6) 2015: additional information received on 11-nov-2015 and 16-nov-15 and 19-nov-15: this spontaneous medical device report was received from two physicians via two different company representatives concerning a female patient, age unknown.The patient's medical history was unknown.The patient's concomitant medications at the time of the event were unknown.The patient received a dose of therasphere, (lot number and expiration date unknown), for a "right lobe treatment" on (b)(6) 2015.On (b)(6) 2015, the patient experienced a therasphere dose being delivered to the gall bladder.It was reported that the microcatheter was in the right hepatic artery and well past the cystic artery.The catheter position was verified prior to the dose infusion and the physicians were confident of the proper placement.The procedure proctor's report noted "the post-infusion spect/ct indicated a very concentrated dose delivered to tumor.Nuclear medicine was confident in a very directed dose delivery".Another reporter reviewed the fused spect/ct image and it appeared that the dose was concentrated in the gall bladder.It was then reported that some small dose did go to the gall bladder but lobe was treated as well and there was no misadministration.The patient was treated with antibiotics and a medrol dose pack.It was reported that the patient was "doing fine." the outcome of the event is unknown.The reporters did not assess the severity of intensity of the event and reported that the event was not related to the device but commented that "as you can't see exactly where the dose goes due to the blind infusion without contrast" and offered an opinion that the entire dose deposited in the gall bladder possibly because the delivery microcatheter flipped or the dose refluxed into the cystic artery.The company considers the event as serious (medically significant).Follow-up information will be requested.Case comment: device use error is considered unlisted according to the current reference safety information.In line with the assessment made by the second physician, the company considers that the event was related to therasphere treatment, the routing of the dose to the gall bladder was likely due to user error.As a corrective measure it was suggested by the treating physicians that they would use fluoroscopy during the next infusion; to verify that there is no catheter movement during the therasphere infusion.The initial pressure on the syringe plunger to administer the dose could result in catheter tip flipping or movement and a defect in the product or the administration kits was ruled out.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: 5252787
• MDR Text Key: 32203094
• Report Number: 3002124545-2015-00092
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• 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
• Report Date: 11/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2015
• 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: 11/05/2015
• 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