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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRUS ENDOVASCULAR, LLC DELTAPLUSH - CERECYTE MICROCOIL; CNV DCS COILS
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MICRUS ENDOVASCULAR, LLC DELTAPLUSH - CERECYTE MICROCOIL; CNV DCS COILS Back to Search Results
Catalog Number CPL10015230
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 07/21/2011
Event Type  malfunction  
Event Description
After several micrus coils (details unknown) were deployed; this coil was used.When the deltaplush cerecyte microcoil 1.5 mm x 2 cm (cpl10015230/g13482) was advanced about 30cm distal to the hub; it got stuck inside the microcatheter (details unknown).So it was safely removed.After this coil; no coil was used and the procedure was finished.The following were used connecting cable (f70554/catalog unknown) and detachment control box (f62190/catalog unknown).There was no resistance felt during dpu/coil deployment.It was noted during analysis that the coil was returned severely damaged.
 
Manufacturer Narrative
After several micrus coils (details unknown) were deployed; this coil was used.When the deltaplush cerecyte microcoil 1.5 mm x 2 cm (cpl10015230/g13482) was advanced about 30cm distal to the hub; it got stuck inside the microcatheter (details unknown).So it was safely removed.After this coil; no coil was used and the procedure was finished.The following were used connecting cable (f70554/catalog unknown) and detachment control box (f62190/catalog unknown).There was no resistance felt during dpu/coil deployment.It was noted during analysis that the coil was returned severely damaged.The coil has been returned severely damaged.The evidence strongly suggests that the interference inside the microcatheter most likely contributed to the coil becoming stuck.The exact source of this blockage is unknown.It also cannot be determined if this interference was of a fixed or detached nature.In addition, without the return of the sl-10 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 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: microcatheter (details unknown); several micrus coils (details unknown); connecting cable (f70554/catalog unknown); detachment control box (f62190/catalog unknown).
 
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Brand Name
DELTAPLUSH - 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 Key4086586
MDR Text Key19804447
Report Number1226348-2014-00541
Device Sequence Number1
Product Code HCG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K083646
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 07/22/2011
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/14/2016
Device Catalogue NumberCPL10015230
Device Lot NumberG13482
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/22/2011
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2011
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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