MAUDE Adverse Event Report: BIOCOMPATIBLES UK LTD THERASPHERE ADMINISTRATION SET (B BRAUN)

Model Number	OTT-SPE-FP-001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The treating physician reported that two administration sets were persistently unwinding at the connection site between the microcatheter and the administration set during a patient case.No leakage, or contamination of microspheres outside the administration set and catheter was reported.The user re-tightened the connection, and allowed the tubing to relax to test the connection.This was repeated until no movement was observed at the connection site.The tubing was noted to retain some of the torque memory to overcome the tightened connection.
Additional Manufacturer Narrative
The manufacturer's assessment was made in reference to the ncrp report 106 (us publication from radiation safety organization), which provides guidance on radiation exposure risks from beta emitting particles (such as y-90) on the skin.The ncrp report 160 notes that approximately 10 billion beta hits are required for acute ulceration of the skin.The dose to deep tissue is negligible, as beta radiation is blocked in both soft and hard tissue.For an acute ulceration of the skin to be cause by the beta-radiation emitted by therasphere, a significant concentration of thousands of spheres would have to be placed in a very small area.This event is exceedingly unlikely in the event of a leak or spill from the microcatheter, as the spheres are substantially dispersed.The nrcp report 106 also states that an exposure of approximately 146 gy to the human skin can cause some reddening.This dose is similar to the planned therapeutic dose when injecting therasphere into a lobe of the liver.The effects of minor radiation exposure to the skin (e.G.Reddening, or sunburn-type symptoms) resolve on their own over the course of weeks.The initial mdr was submitted conservatively while a full impact assessment of the reported radiation contamination was performed.The assessment concluded that no serious injury occured in this event from the reported malfunction, nor could it occur if the malfunction were to recur.
Event or Problem Description
The treating physician reported that two administration sets were persistently unwinding at the connection site between the microcatheter and the administration set during a patient case.No leakage or contamination of microspheres outside the administration set and catheter was reported.The user re-tightened the connection, and allowed the tubing to relax to test the connection.This was repeated until no movement was observed at the connection site.The tubing was noted to retain some of the torque memory to overcome the tightened connection.

• Brand Name: THERASPHERE ADMINISTRATION SET (B BRAUN)
• Common Device Name: THERASPHERE
• Manufacturer (Section D): BIOCOMPATIBLES UK LTD; chapman house farnham bus park; weydon lane; farnham, GU9 8 QL; UK GU9 8QL
• MDR Report Key: 10972532
• Report Number: 3002124543-2020-00025
• Device Sequence Number: 17197237
• Product Code: NAW
• UDI-Device Identifier: 05060116920635
• UDI-Public: 05060116920635
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: H980006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: OTT-SPE-FP-001
• Device Lot Number: 0061673700
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1