MAUDE Adverse Event Report: BIOSPHERE MEDICAL SA EMBOCUBE®.PRE-FILLED SYRINGE.STERILE; EMBOLIZATION DEVICE

Catalog Number	EC2550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Embolism/Embolus (4438)
Date of Event	03/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.
Event or Problem Description
The account alleges that during a vascular embolization procedure within the patient's liver, the patient had coded on the procedure table, the medical team was using red contrast syringes during this procedure for fluoroscopic imaging, during the patient code, it was first reported that the medical team may have inadvertently grabbed a red embolic syringe thinking it was contrast syringe and injected the embolic into the patient's vascular system.It was also reported that the physician did an extensive "post-procedure" review of events that took place and believes that the patient may have experienced reflux of the embolic material that led to non-target embolization instead.Regardless the embolic product allegedly migrated to the patient's lower leg.The patient was referred to surgery for amputation.The patient was critically ill suffering from simultaneous comorbidities and pre-existing complications at the time.

• Brand Name: EMBOCUBE®.PRE-FILLED SYRINGE.STERILE
• Common Device Name: EMBOLIZATION DEVICE
• Manufacturer (Section D): BIOSPHERE MEDICAL SA; parc des nations-paris nord 2; 383 rue de la belle etole; roissy en, 95700 ; FR 95700
• Manufacturer (Section G): BIOSPHERE MEDICAL SA; parc des nations-paris nord 2; 383 rue de la belle etole; roissy en, 95700 ; FR 95700
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012088662
• MDR Report Key: 19028606
• Report Number: 9615728-2024-00004
• Device Sequence Number: 15462735
• Product Code: KRD
• UDI-Device Identifier: 00884450306208
• UDI-Public: 884450306208
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K183120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/05/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: EC2550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONTRAST SYRINGES
• Outcome Attributed to Adverse Event: Hospitalization; Disability; Other
• Patient Sex: Female