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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 RBY2C0512-A
Medical Device Problem Codes Kinked (1339); Device Handling Problem (3265)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 03/01/2016
Type of Reportable Event Malfunction
Additional 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.
 
Event or Problem Description
During preparation for a thrombectomy procedure, the physician inadvertently kinked the ruby coil pusher assembly upon removal from the packaging.The ruby coil pusher assembly was kinked prior to use.Therefore, the ruby coil was not used for the procedure and a new ruby coil was opened to complete the procedure.
 
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Brand Name
RUBY COIL
Common Device Name
HCG, KRD
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key5529494
Report Number3005168196-2016-00385
Device Sequence Number16237591
Product Code HCG
UDI-Device Identifier00814548012896
UDI-Public00814548012896
Combination Product (Y/N)N
PMA/510(K) Number
K120330
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 03/01/2016
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
Operator of Device Physician
Device Expiration Date08/31/2022
Device Catalogue NumberRBY2C0512-A
Device Lot NumberF60510
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/01/2016
Initial Report FDA Received Date03/28/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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