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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BIOSPHERE MEDICAL SA EMBOSPHERE MICROSPHERES
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BIOSPHERE MEDICAL SA EMBOSPHERE MICROSPHERES Back to Search Results
Catalog Number S220GH-003/A
Device Problems Failure to Deliver (2338); Failure to Infuse (2340)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/11/2019
Event Type  malfunction  
Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
 
Event Description
The account alleges that during preparations for an embolic procedure, a string like particle was identified within an embolic syringe.The device was not use for the procedure, no patient injury to report.
 
Manufacturer Narrative
The suspect device was returned for evaluation.The complaint is confirmed.Because the returned microspheres had been mixed with contrast media, it is unknown if the foreign object was introduced during manufacturing or mixing.The root cause is unknown.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were found.
 
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Brand Name
EMBOSPHERE MICROSPHERES
Type of Device
MICROSPHERES
Manufacturer (Section D)
BIOSPHERE MEDICAL SA
parc des nations, paris nord 2
383, rue de la belle etoile
95700
FR  95700
MDR Report Key8878701
MDR Text Key186753322
Report Number9615728-2019-00005
Device Sequence Number1
Product Code NAJ
Combination Product (y/n)N
PMA/PMN Number
K021397
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Type of Report Initial,Followup
Report Date 07/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2021
Device Catalogue NumberS220GH-003/A
Device Lot NumberX1479070
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/15/2019
Date Manufacturer Received09/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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