• 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. PX SLIM DELIVERY MICROCATHETER DQY

  • 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. PX SLIM DELIVERY MICROCATHETER DQY Back to Search Results
Model Number PXSLIMSTR-B
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/19/2021
Event Type  malfunction  
Manufacturer Narrative
This device is available for return. A follow up mdr will be submitted upon completion of the device investigation.
 
Event Description
The patient was undergoing a medical procedure using a px slim delivery microcatheter (px slim). During the procedure, the physician experienced resistance while advancing the px slim. Therefore, the px slim was removed. Upon removal, it was noted that the proximal end of the px slim was broken. The procedure was completed using a new px slim. There was no report of an adverse effect to the patient.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePX SLIM DELIVERY MICROCATHETER
Type of DeviceDQY
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key12014224
MDR Text Key259471483
Report Number3005168196-2021-01347
Device Sequence Number1
Product Code DQY
Combination Product (y/n)Y
Reporter Country CodeBR
PMA/PMN Number
K100826
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,08/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPXSLIMSTR-B
Device Catalogue NumberPXSLIMSTR
Device Lot NumberF100620
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/20/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received08/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-