MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBSIDIO; VASCULAR EMBOLIZATION DEVICE

Model Number	M0013972101010
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330); Numbness (2415); Embolism/Embolus (4438)
Date of Event	08/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that dislodgement occurred requiring additional intervention.Obsidio was selected for an embolization procedure.The obsidio was delivered through a coil pack from a previous case that had recanalized.The standard delivery of obsidio went smoothly.During an attempt to remove the microcatheter, by pulling it back through the coil pack post embolization, the microcatheter may have been kinked causing a portion of the obsidio material to become loose from the microcatheter and go distal as the microcatheter was pulled out at the arterial branch.The dislodged embolic material went distal causing perfusion of vessels that supply the hand/fingers.The physicians attempted to suck out the sheered material, using aspiration, which caused it to go even more distal and further sheer.Immediately following the embolization procedure, the patient experienced pain and discomfort.An unknown intervention was used to treat the pain.The patient was admitted to the hospital.The patient has since recovered and was discharged.
Additional Manufacturer Narrative
A2: age at time of event: under 18.B3: date of event: boston scientific has been unable to obtain additional information regarding the date of event, despite good faith efforts.
Event or Problem Description
It was reported that dislodgement occurred requiring additional intervention.Obsidio was selected for an embolization procedure.The obsidio was delivered through a coil pack from a previous case that had recanalized.The standard delivery of obsidio went smoothly.During an attempt to remove the microcatheter, by pulling it back through the coil pack post embolization, the microcatheter may have been kinked causing a portion of the obsidio material to become loose from the microcatheter and go distal as the microcatheter was pulled out at the arterial branch.The dislodged embolic material went distal causing perfusion of vessels that supply the hand/fingers.The physicians attempted to suck out the sheered material, using aspiration, which caused it to go even more distal and further sheer.Immediately following the embolization procedure, the patient experienced pain and discomfort.An unknown intervention was used to treat the pain.The patient was admitted to the hospital.The patient has since recovered and was discharged.It was further reported that there was a short landing zone due to the previous coil pack and there were no other embolic options.There was 0.2ml of obsidio injected through a truselect microcatheter into the existing coil pack.A proper cast formed and the microcatheter was applied with negative pressure and slowly pulled back.The microcatheter moved forward a bit before coming back when removing the catheter, dislodging the proximal cast and pulling it back with the catheter appearing to be stuck to the catheter.As the microcatheter was pulled back, this caused non target embolization down the ulnar artery into the palm of the hand.A non-boston scientific aspiration system was used in an attempt to retrieve the obsidio; however, the thrombectomy caused further distal embolization into the digits.The patient experienced numbness tingling in the fingers.The patient is doing well, and the symptoms have resolved.

• Brand Name: OBSIDIO
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): OBSIDIO, INC.; 2 scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21322195
• Report Number: 2124215-2025-06186
• Device Sequence Number: 20953676
• Product Code: KRD
• UDI-Device Identifier: 00191506043124
• UDI-Public: 00191506043124
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K213385
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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 Expiration Date: 03/31/2025
• Device Model Number: M0013972101010
• Device Catalogue Number: M0013972101010
• Device Lot Number: 0000401241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/11/2025
• Date Device Manufactured: 04/01/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 12 YR
• Patient Sex: Male