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. POD5; 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. POD5; HCG, KRD Back to Search Results
Catalog Number RBYPOD5
Medical Device Problem Codes Defective Device (2588); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code Urinary Retention (2119)
Date of Event 08/31/2018
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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.
 
Event or Problem Description
The patient was undergoing a coil embolization procedure using pod5s.During the procedure, the physician felt resistance while advancing a pod5 within a lantern delivery microcatheter (lantern) and, therefore, the pod5 was removed.It was noted that there was damage to the pod5.The procedure was completed using ruby coils and the same lantern.There was no report of an adverse effect to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
POD5
Common Device Name
HCG, KRD
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
MDR Report Key7924208
Report Number3005168196-2018-01941
Device Sequence Number16557493
Product Code HCG
UDI-Device Identifier00814548013787
UDI-Public00814548013787
Combination Product (Y/N)Y
Initial Reporter StateSD
Initial Reporter CountryUS
PMA/510(K) Number
K141134
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
Report Date (Section B) 09/04/2018
Report Date (Section F) 01/01/2005
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 Health Professional
Device Catalogue NumberRBYPOD5
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report to Manufacturer01/10/2005
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/04/2018
Initial Report FDA Received Date10/01/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Patient Age81 YR
Date Report Sent to FDA01/01/2005
-
-