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	11/02/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The treating physician reported that a microcatheter persistently detached from the administration set during a patient case, resulting in a major spill of therasphere microspheres at the site of connection between the therasphere administration set and the microcatheter.The spill contaminated the drape, towels, floor and surrounding area of the operating room.The spill reached the shoes of the attending staff, as well as the gloves of the treating physician.The treating operating room was shut down for the remainder of the day.
Event or Problem Description
The treating physician reported that a microcatheter persistently detached from the administration set during a patient case, resulting in a major spill of therasphere microspheres at the site of connection between the therasphere administration set and the microcatheter.The spill contaminated the drape, towels, floor and surrounding area of the operating room.The spill reached the shoes of the attending staff, as well as the gloves of the treating physician.The treating operating room was shut down for the remainder of the day.
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 incident report of the event describes the measured radiation fields at the location of the contamination.The initial contamination of the left palm measured > 0.1 mr/h.The contamination (spheres) was washed off with soap and water, and the field decreased to background (no detectible radiation field).Assuming that the decontamination process took 1 hour (a very conservative overestimate), the palm would have exposed to 0.1 mr.For beta emitters, 1 r deposits about 0.96 rem in soft tissue (skin).When comparing this exposure to the regulated limit for occupational hand exposure (50 rem per year, [ref 10 cfr part 20.1201]), the estimated exposure in this case (assuming 1 hour of exposure) would be 0.1 * 0.96 / 1000 = 9.6 x 10^-5 rem, or 0.000192% of the annual limit.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.This dose would require extended exposure of therasphere y-90 to the skin for the appropriate decay to occur.The reporter and treating physician decontaminated following the procedure and reached background radiation exposure.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.

• 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: 10932400
• Report Number: 3002124543-2020-00024
• Device Sequence Number: 2322502
• 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: 11/03/2020
• Supplement Date Received by Manufacturer: 12/11/2020
• Initial Report FDA Received Date: 12/02/2020
• 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