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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC MICRUSPHERE 10 - PLATINUM MICROCOIL; CNV DCS COILS
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MICRUS ENDOVASCULAR, LLC MICRUSPHERE 10 - PLATINUM MICROCOIL; CNV DCS COILS Back to Search Results
Catalog Number SPH10030020
Device Problems Stretched (1601); Impedance Problem (2950)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/30/2011
Event Type  malfunction  
Event Description
It was impossible to push the micrusphere 10 platinum microcoil 3 mm x 5.4 cm (sph10030020/ f66814) forward.A boston 6f microcatheter (details unknown) was used.It was noted during analysis that the coil was returned stretched.
 
Manufacturer Narrative
It was impossible to push the micrusphere 10 platinum microcoil 3 mm x 5.4 cm (sph10030020/ f66814) forward.A boston 6f microcatheter (details unknown) was used.It was noted during analysis that the coil was returned stretched.The coil was returned stretched.The evidence suggests that interference contributed to the coil not being able to be pushed forward.The source and location of this interference cannot be determined.It is unknown if the interference was of a fixed or detached nature.In addition, without the return of the microcatheter used in the procedure, it cannot be determined if this component contributed to the complaint event.Based on the information and the analysis, the event ¿coil unraveled/stretched¿ was confirmed and the event ¿dcs impeded¿ could not be confirmed.No corrective actions will be taken at this time.This mdr is being submitted as part of a retrospective review as the result of a recent fda audit and with accordance to the requirements of code of federal regulations ¿ 21 cfr part 803, medical device reporting.Concomitant medical products and therapy dates: boston 6f microcatheter (details unknown).
 
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Brand Name
MICRUSPHERE 10 - PLATINUM MICROCOIL
Type of Device
CNV DCS COILS
Manufacturer (Section D)
MICRUS ENDOVASCULAR, LLC
821 fox lane
san jose CA 95131
Manufacturer (Section G)
CODMAN AND SHURTLEFF, INC (SAN JOSE)
821 fox lane
san jose CA 95131
Manufacturer Contact
duane durbin
miami lakes, FL 33014
5088283106
MDR Report Key4086671
MDR Text Key4827400
Report Number1226348-2014-00563
Device Sequence Number1
Product Code HCG
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K002056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 08/15/2011
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/28/2016
Device Catalogue NumberSPH10030020
Device Lot NumberF66814
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/15/2011
Initial Date FDA Received09/12/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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