Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. RUBY COIL; HCG, KRD
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PENUMBRA, INC. RUBY COIL; HCG, KRD Back to Search Results
Catalog Number RBY4C0620
Medical Device Problem Code Failure to Advance (2524)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 04/20/2018
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
The patient was undergoing a coil embolization procedure using ruby coils.During the procedure, a ruby coil was unable to advance out of the microcatheter.
 
Additional Manufacturer Narrative
The device was discarded.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
RUBY COIL
Common Device Name
HCG, KRD
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key7534274
Report Number3005168196-2018-01028
Device Sequence Number134476
Product Code HCG
UDI-Device Identifier00814548013183
UDI-Public00814548013183
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K120330
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 04/24/2018
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 Date11/26/2025
Device Catalogue NumberRBY4C0620
Device Lot NumberF80733
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 04/24/2018
Supplement Date Received by Manufacturer04/24/2018
Initial Report FDA Received Date05/22/2018
Supplement Report FDA Received Date05/22/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-