MAUDE Adverse Event Report: BIOCOMPATIBLES UK LIMITED TS ADMIN SET-CEA (990226.SPE)-1 BOX; MICROSPHERES RADIONUCLIDE

Model Number	M00139553CEA0
Medical Device Problem Codes	Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993); Radiation Underexposure (3018)
Health Effect - Clinical Codes	Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a procedural related dissection occurred.In (b)(6) 2020, a misadministration of therasphere y-90 microspheres occurred.The physician was unable to inject the therasphere from the delivery apparatus into the patient.Seven days later, a repeat procedure was attempted, however, the injection attempt failed.During this procedure, stenosis in the femoral artery was identified.The patient was given blood thinners.The stenosis is thought to be either the dissection of the arterial wall from the non-bsc closure device, or it was the displaced closure device itself from the first therasphere procedure.In late (b)(6) 2020, the patient reported difficulty in walking, their leg would go numb and essentially feel dead and heavy.The patient sought medical advice.After imaging of the artery was completed, the patient learned that the closure device had collapsed into the artery and the arterial wall suffered a dissection.In (b)(6) 2021, a surgeon who specializes in arterial surgery attempted to repair the dissected arterial wall and remove the collapsed angioseal device, however, the patient still experiences leg numbness.
Event or Problem Description
It was reported that a procedural related dissection occurred.On (b)(6) 2020 the physician was unable to inject the therasphere y-90 microspheres from the delivery apparatus into the patient.On (b)(6) 2020, a repeat procedure was attempted, however, the injection attempt failed.During this procedure, stenosis in the femoral artery was identified.The patient was given blood thinners.The stenosis was thought to be either the dissection of the arterial wall from the non-boston scientific closure device, or it was the displaced closure device itself from the first therasphere procedure.In late (b)(6) 2020, the patient reported difficulty in walking, their leg would go numb and essentially feel dead and heavy.The patient sought medical advice.After imaging of the artery was completed, the patient learned that the closure device had collapsed into the artery and the arterial wall suffered a dissection.The closure device that was used to close the femoral artery failed, resulting in a dissection in the patient's arterial wall.On (b)(6) 2021, a surgeon who specializes in arterial surgery attempted to repair the dissected arterial wall and remove the collapsed angioseal device, however, the patient still experiences leg numbness.

• Brand Name: TS ADMIN SET-CEA (990226.SPE)-1 BOX
• Common Device Name: MICROSPHERES RADIONUCLIDE
• Manufacturer (Section D): BIOCOMPATIBLES UK LIMITED; chapman house; weydon lane, farnham; surrey ; UK
• Manufacturer (Section G): BIOCOMPATIBLES UK LIMITED; chapman house; weydon lane, farnham; surrey ; UK
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12668230
• Report Number: 2134265-2021-13196
• Device Sequence Number: 17218064
• Product Code: NAW
• UDI-Device Identifier: 05060116920253
• UDI-Public: 5060116920253
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00139553CEA0
• Device Catalogue Number: 2361-06
• Device Lot Number: 196D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 01/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABBOTT ANGIOSEAL CLOSURE DEVICE; ABBOTT ANGIOSEAL CLOSURE DEVICE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female