MAUDE Adverse Event Report: EMBOLX INC. SNIPER BALLOON OCCLUSION MICROCATHETER; CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY

Catalog Number	SBC0629-STR-150
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient undergoing yttrium-90 radioembolization of liver metastasis from rectal cancer.Balloon occlusion catheter deployed in right hepatic artery ostensibly to direct radioactive spheres to the target area while preventing nontarget embolization to bowel and the remainder of the liver not containing tumor.Two consecutive sniper balloon microcatheters failed, the first before any radioactive beads had been administered through it and the second during administration of an aliquot of radioactive beads.Removing the second microcatheter exposed the patient to the possibility of reflux of the particles into the gastroduodenal artery and nontarget embolization to the bowel and remainder of the liver.Ultimately, a third balloon occlusion microcatheter by different manufacturer was able to be successfully used to achieve treatment without a misadministration (defined as delivering less than 75% of the dose in the written directive) and without nontarget embolization of the radioembolization to bowel.The nature of the failure has been seen previously with the catheter - specifically, the balloon inflation lumen communicates with the true catheter lumen and the balloon decompresses spontaneously.As such, it no longer functions as a balloon occlusion catheter and puts the patient in danger of reflux of the injected substance."lb-0504 rev c.(b)(4) emx11032202; (b)(4) emx12142201." reference report: mw5147618.

• Brand Name: SNIPER BALLOON OCCLUSION MICROCATHETER
• Common Device Name: CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY
• Manufacturer (Section D): EMBOLX INC.; sunnyvale CA 94085
• MDR Report Key: 18055574
• Report Number: MW5147617
• Device Sequence Number: 15100800
• Product Code: MJN
• UDI-Device Identifier: 00853359008032
• UDI-Public: 00853359008032
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2023

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 Expiration Date: 11/03/2023
• Device Catalogue Number: SBC0629-STR-150
• Device Lot Number: EMX110322-02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 90Y RESIN MICROSPHERES (SIR SPHERES).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 89 KG
• Patient Race: White