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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC PRESIDIO 10 - CERECYTE MICROCOIL; CNV DCS COILS
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MICRUS ENDOVASCULAR, LLC PRESIDIO 10 - CERECYTE MICROCOIL; CNV DCS COILS Back to Search Results
Catalog Number PC410062630
Device Problems Impedance Problem (2950); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/12/2010
Event Type  malfunction  
Event Description
Ica aneurysm long and difficult to catheterize.When they went to push the first coil presidio 10 cerecyte microcoil 6 mm x 26 cm (pc410062630/f62788); it was impossible to progress in the echelon 14 microcatheter (details unknown).So they change the coil and it was ok.It was noted during analysis that the entire coil was returned severely damaged.
 
Manufacturer Narrative
Ica aneurysm long and difficult to catheterize.When they went to push the first coil presidio 10 cerecyte microcoil 6 mm x 26 cm (pc410062630/f62788); it was impossible to progress in the echelon 14 microcatheter (details unknown).So they change the coil and it was ok.It was noted during analysis that the entire coil was returned severely damaged.The entire coil was returned severely damaged.Therefore, the root cause of the coil's advancement difficulty cannot be determined.In addition, without the return of the echelon 14 microcatheter and the hemostatic valve, it cannot be determined if these components contributed to the complaint event.Based on the information and the analysis, the event ¿coil damaged¿ was confirmed and the event ¿dcs impeded-in microcatheter¿ 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: echelon 14 microcatheter (details unknown); new coil (details unknown).
 
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Brand Name
PRESIDIO 10 - CERECYTE 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 Key4085669
MDR Text Key4894643
Report Number1226348-2014-00517
Device Sequence Number1
Product Code HCG
Combination Product (y/n)N
Reporter Country CodeFR
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 10/25/2010
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 Date07/03/2015
Device Catalogue NumberPC410062630
Device Lot NumberF62788
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/25/2010
Initial Date FDA Received09/12/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2010
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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