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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. RUBY COIL DETACHMENT HANDLE; HCG, KRD
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PENUMBRA, INC. RUBY COIL DETACHMENT HANDLE; HCG, KRD Back to Search Results
Catalog Number RH1-A
Device Problems Component Falling (1105); Device Handling Problem (3265)
Patient Problem No Patient Involvement (2645)
Event Date 07/22/2015
Event Type  malfunction  
Manufacturer Narrative
The product was not returned for evaluation.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.The hospital disposed of the device.
 
Event Description
During preparation for a coil embolization procedure, the ruby detachment handle (handle) was dropped.The dropped handle occurred prior to use; therefore it was not used during the procedure.The procedure was completed using a new handle.
 
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Brand Name
RUBY COIL DETACHMENT HANDLE
Type of Device
HCG, KRD
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
kathleen kidd
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key5675872
MDR Text Key45784930
Report Number3005168196-2016-00715
Device Sequence Number1
Product Code HCG
UDI-Device Identifier00814548013268
UDI-Public00814548013268
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K120330
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 04/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2017
Device Catalogue NumberRH1-A
Device Lot NumberF47390
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/28/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/18/2014
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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