MAUDE Adverse Event Report: OBSIDIO, INC. OBSIDIO; VASCULAR EMBOLIZATION DEVICE

Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Ischemia (1942); Pain (1994); Bowel Perforation (2668); Embolism/Embolus (4438); Fecal Incontinence (4571)
Date of Event	11/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient complications occurred requiring additional intervention.Obsidio was used for a rectal artery embolization of acute rectal bleeding.The patient was admitted with an acute massive lower gastrointestinal (gi) bleed that measured -2mm.Computed tomography angiography (cta) revealed an active rectal artery branch bleeding with contrast extravasation from the right side of the rectum.An angiogram revealed a similar finding, and the patient underwent selective rectal artery branch embolization with obsidio.A 2.4 fr non-boston scientific microcatheter was used with 0.1 ml of obsidio using the aliquot technique.The physician was pleased with the delivery of obsidio with cessation of bleeding.The patient had decrease in hemoglobin and minimal rectal bleeding and underwent a computed tomography (ct) 2 days after the initial embolization procedure.The ct revealed a rent in the rectal wall at the site of the initial bleeding and embolization.Obsidio was noted to be 2cm more distal in the artery and rectal wall compared with the post procedure angiogram/fluoroscopic images, which led to ischemia.The patient underwent a colonoscopy which demonstrated focal perforation without infection or abscess.The patient was experiencing pain at the site and underwent a diverting colostomy 3 weeks post embolization.The patient was experiencing anal incontinence coincident with the perforation.
Event or Problem Description
It was reported that patient complications occurred requiring additional intervention.Obsidio was used for a rectal artery embolization of acute rectal bleeding.The patient was admitted with an acute massive lower gastrointestinal (gi) bleed that measured -2mm.Computed tomography angiography (cta) revealed an active rectal artery branch bleeding with contrast extravasation from the right side of the rectum.An angiogram revealed a similar finding, and the patient underwent selective rectal artery branch embolization with obsidio.A 2.4 fr non-boston scientific microcatheter was used with 0.1 ml of obsidio using the aliquot technique.The physician was pleased with the delivery of obsidio with cessation of bleeding.The patient had decrease in hemoglobin and minimal rectal bleeding and underwent a computed tomography (ct) 2 days after the initial embolization procedure.The ct revealed a rent in the rectal wall at the site of the initial bleeding and embolization.Obsidio was noted to be 2cm more distal in the artery and rectal wall compared with the post procedure angiogram/fluoroscopic images, which led to ischemia.The patient underwent a colonoscopy which demonstrated focal perforation without infection or abscess.The patient was experiencing pain at the site and underwent a diverting colostomy 3 weeks post embolization.The patient was experiencing anal incontinence coincident with the perforation.
Additional Manufacturer Narrative
Evaluation conclusion codes (1): corrected from cmc - unintended use error caused or contributed to event to adverse event related to procedure.

• Brand Name: OBSIDIO
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): OBSIDIO, INC.; 2 scimed pl; maple grove 55331
• Manufacturer (Section G): OBSIDIO; 2 scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18602410
• Report Number: 2124215-2024-01170
• Device Sequence Number: 14133962
• Product Code: KRD
• UDI-Device Identifier: 00191506043124
• UDI-Public: 00191506043124
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K213385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/12/2024

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?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 04/12/2024
• 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: MICROCATHETER: 2.4FR PROGREAT.; MICROCATHETER: 2.4FR PROGREAT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Unknown