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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Pain (1994); Ulcer (2274); Embolism/Embolus (4438)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: age at time of event: patient in his 40s.
Event or Problem Description
It was reported that the patient experienced complications and was hospitalized.Obsidio was selected for hemorrhoidal artery embolization of the bilateral superior and middle rectal arteries in all 4-5 branches.The size of the vessels were less than 3mm.The physician described variable feel of delivering obsidio in each of the arteries using the aliquot technique.The patient experienced a moderate amount of pain one day post procedure.Two days post procedure, the patient experienced improved pain and the patient returned to work.Four weeks post procedure, the patient was admitted to the hospital with increased rectal pain and minimal bleeding.The patient developed rectal ischemia in the same location the obsidio was placed.The patient underwent proctoscopy which revealed focal ulceration in the rectum without perforation.Obsidio was also observed proximal to the target lesion.Endoscopic clipping was performed.The patient status is stable.The patient was discharged the next day and has recovered.
Additional Manufacturer Narrative
A2: age at time of event: patient in his 40s.D4: unique identifier (udi) #: updated from (b)(4) to (b)(4).H6: evaluation conclusion codes (1): updated from cmc-no problem detected to unintended use error caused or contributed to event.
Event or Problem Description
It was reported that the patient experienced complications and was hospitalized.Obsidio was selected for hemorrhoidal artery embolization of the bilateral superior and middle rectal arteries in all 4-5 branches.The size of the vessels were less than 3mm.The physician described variable feel of delivering obsidio in each of the arteries using the aliquot technique.The patient experienced a moderate amount of pain one day post procedure.Two days post procedure, the patient experienced improved pain and the patient returned to work.Four weeks post procedure, the patient was admitted to the hospital with increased rectal pain and minimal bleeding.The patient developed rectal ischemia in the same location the obsidio was placed.The patient underwent proctoscopy which revealed focal ulceration in the rectum without perforation.Obsidio was also observed proximal to the target lesion.Endoscopic clipping was performed.The patient status is stable.The patient was discharged the next day and has recovered.
Additional Manufacturer Narrative
A2: age at time of event: patient in his 40s.D4: unique identifier (udi) #: updated from (b)(4) to (b)(4).H6: evaluation conclusion codes (1): updated from cmc-no problem detected to unintended use error caused or contributed to event.
Event or Problem Description
It was reported that the patient experienced complications and was hospitalized.Obsidio was selected for hemorrhoidal artery embolization of the bilateral superior and middle rectal arteries in all 4-5 branches.The size of the vessels were less than 3mm.The physician described variable feel of delivering obsidio in each of the arteries using the aliquot technique.The patient experienced a moderate amount of pain one day post procedure.Two days post procedure, the patient experienced improved pain and the patient returned to work.Four weeks post procedure, the patient was admitted to the hospital with increased rectal pain and minimal bleeding.The patient developed rectal ischemia in the same location the obsidio was placed.The patient underwent proctoscopy which revealed focal ulceration in the rectum without perforation.Obsidio was also observed proximal to the target lesion.Endoscopic clipping was performed.The patient status is stable.The patient was discharged the next day and has recovered.It was further reported that approximately 7 months post procedure, the patient presented with symptoms of worsening rectal pain.The patient underwent a colonoscopy which demonstrated multiple ischemic strictures in the rectum along with diffuse black discoloration throughout the region.The black discoloration was thought to represent the color of obsidio staining the lumen.The patient is being referred to a specialist for additional intervention.

• 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: 18487071
• Report Number: 2124215-2023-75805
• Device Sequence Number: 14336142
• Product Code: KRD
• UDI-Device Identifier: 00191506043124
• UDI-Public: 00191506043124
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 07/24/2024

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
• 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: 12/12/2023
• Supplement Date Received by Manufacturer: 01/16/2024; 06/28/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/09/2024; 07/24/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Male