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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. RUBY COIL; HCG, KRD

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PENUMBRA, INC. RUBY COIL; HCG, KRD Back to Search Results
Catalog Number RBY2C0630
Device Problems Failure to Advance (2524); Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/20/2017
Event Type  malfunction  
Manufacturer Narrative
The product was disposed of by the hospital and is no longer available for return.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 3005168196-2017-02263.The hospital disposed of the device.
 
Event Description
The patient was undergoing a coil embolization procedure in the splenic artery using ruby coils.During the procedure, while attempting to advance two ruby coils through the non-penumbra microcatheter, the physician did not mention feeling any resistance; however, the coils became stuck and were unable to advance out of the microcatheter.Therefore, the ruby coils were removed and the procedure was then completed using new ruby coils and the same microcatheter.There was no report of an adverse effect to the patient.
 
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Brand Name
RUBY COIL
Type of Device
HCG, KRD
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key7131212
MDR Text Key95910408
Report Number3005168196-2017-02262
Device Sequence Number1
Product Code HCG
UDI-Device Identifier00814548012940
UDI-Public00814548012940
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K120330
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 11/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Catalogue NumberRBY2C0630
Device Lot NumberF79808
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/04/2017
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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