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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OBSIDIO, INC. OBSIDIO; VASCULAR EMBOLIZATION DEVICE
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OBSIDIO, INC. OBSIDIO; VASCULAR EMBOLIZATION DEVICE Back to Search Results
Lot Number 0000320231
Device Problem Use of Device Problem (1670)
Patient Problems Obstruction/Occlusion (2422); Embolism/Embolus (4438)
Event Date 10/25/2023
Event Type  Injury  
Manufacturer Narrative
A2: age at time of event: over 18 years.
 
Event 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.
 
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 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.
 
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Brand Name
OBSIDIO
Type of Device
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 Key18184607
MDR Text Key328698802
Report Number2124215-2023-65027
Device Sequence Number1
Product Code KRD
UDI-Device Identifier00191506039332
UDI-Public00191506039332
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K213385
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 12/14/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0000320231
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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