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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 RBY4C0415
Device Problems Break (1069); Detachment Of Device Component (1104); Premature Activation (1484)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/14/2017
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 device was implanted in the patient.
 
Event Description
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, the physician successfully deployed and detached multiple ruby coils using a lantern delivery microcatheter (lantern).A ruby coil then unintentionally detached within the lantern as the lantern backed in to the non-penumbra sheath.The physician attempted to remove the lantern with the ruby coil inside, however the ruby coil remained in the sheath; therefore, the physician pulled out the ruby coil using his fingers.As the ruby coil was being pulled out, the coil broke into two pieces.The physician removed one piece, and the second piece flowed into the target location; therefore, it was left in place.The procedure ended at this point.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 Key6855587
MDR Text Key86150436
Report Number3005168196-2017-01531
Device Sequence Number1
Product Code HCG
UDI-Device Identifier00814548013176
UDI-Public00814548013176
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120330
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 08/14/2017
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 No Information
Device Expiration Date03/29/2024
Device Catalogue NumberRBY4C0415
Device Lot NumberF68732
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/14/2017
Initial Date FDA Received09/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age70 YR
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