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

Lot Number	0000320231
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Embolism/Embolus (4438)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A2: age at time of event: over 18 years.
Event or Problem Description
It was reported that obsidio embolized.The target location was in the gastroduodenal artery (gda).The vessel size was 1 - 3mm.Obsidio was selected for use.After creating casting of the obsidio, the fellow was instructed by the physician to administer a large bolus of saline and obsidio material through aliquot technique.The reason for the use of the aliquot method was to re-use the microcatheter.The aliquot method resulted in a total of.6 ml of obsidio being used and the catheter, in use, being placed too close to the obsidio casting.The obsidio from the second bolus/aliquot, moved towards the branch point of the right hepatic artery.The flow of the vessel and injection of contrast during a hand injection run took the obsidio even more distal.The obsidio shut down the right hepatic artery supply.Action was taken to break up the obsidio into pieces using a microcatheter.Smaller pieces of obsidio traveled distally to the pancreas.Minor flow was achieved but not entirely.Imaging, post procedure, revealed the patient had pancreas flow shut down resulting into other complications like pancreas infarct.
Additional Manufacturer Narrative
A2: age at time of event: over 18 years.Image evaluation by mfr: the complaint device was not received for analysis.The site provided images of the embolized vessel, confirming the events of vessel occlusion and embolism.H3 other text: no device was returned.Images were reviewed.
Event or Problem Description
It was reported that obsidio embolized.The target location was in the gastroduodenal artery (gda).The vessel size was 1 - 3mm.Obsidio was selected for use.After creating casting of the obsidio, the fellow was instructed by the physician to administer a large bolus of saline and obsidio material through aliquot technique.The reason for the use of the aliquot method was to re-use the microcatheter.The aliquot method resulted in a total of.6 ml of obsidio being used and the catheter, in use, being placed too close to the obsidio casting.The obsidio from the second bolus/aliquot, moved towards the branch point of the right hepatic artery.The flow of the vessel and injection of contrast during a hand injection run took the obsidio even more distal.The obsidio shut down the right hepatic artery supply.Action was taken to break up the obsidio into pieces using a microcatheter.Smaller pieces of obsidio traveled distally to the pancreas.Minor flow was achieved but not entirely.Imaging, post procedure, revealed the patient had pancreas flow shut down resulting into other complications like pancreas infarct.
Event or Problem Description
It was reported that obsidio embolized.The target location was in the gastroduodenal artery (gda).The vessel size was 1 - 3mm.Obsidio was selected for use.After creating casting of the obsidio, the fellow was instructed by the physician to administer a large bolus of saline and obsidio material through aliquot technique.The reason for the use of the aliquot method was to re-use the microcatheter.The aliquot method resulted in a total of.6 ml of obsidio being used and the catheter, in use, being placed too close to the obsidio casting.The obsidio from the second bolus/aliquot, moved towards the branch point of the right hepatic artery.The flow of the vessel and injection of contrast during a hand injection run took the obsidio even more distal.The obsidio shut down the right hepatic artery supply.Action was taken to break up the obsidio into pieces using a microcatheter.Smaller pieces of obsidio traveled distally to the pancreas.Minor flow was achieved but not entirely.Imaging, post procedure, revealed the patient had pancreas flow shut down resulting into other complications like pancreas infarct.It was further reported that the gda was treated additionally with two 4mmx6cm coils.Subsequent contrast injection demonstrated no further extravasation and no flow to the gda.Diminished hepatic artery (rha) flow due to non-target embolization was also noted.Attempts were made to macerate the migrated conformable embolic with vigorous saline flushes via the microcatheter.Balloon maceration was also performed with a balloon occlusion microcatheter.This resulted in improved but persistently diminished flow within the rha and may have led to additional non-target embolization.
Additional Manufacturer Narrative
Image evaluation by mfr: the complaint device was not received for analysis.The site provided images of the embolized vessel, confirming the events of vessel occlusion and embolism.

• 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; 2 scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18184607
• Report Number: 2124215-2023-65027
• Device Sequence Number: 7611029
• Product Code: KRD
• UDI-Device Identifier: 00191506039332
• UDI-Public: 00191506039332
• 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: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2025

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: 02/28/2025
• Device Lot Number: 0000320231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 11/22/2023; 01/08/2025
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/14/2023; 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2023
• 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: BALLOON OCCLUSION MICROCATHETER: EMBOLX SNIPER; CATHETER: COOK 5F COBRA; MICROCATHETER: 2.8F TERUMO PROGREAT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female