• 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. INDIGO SYSTEM ASPIRATION CATHETER 8; DXE

  • 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. INDIGO SYSTEM ASPIRATION CATHETER 8; DXE Back to Search Results
Device Problems Kinked (1339); Device Handling Problem (3265)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/07/2017
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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.Reason for no return is pending.
 
Event Description
The patient was undergoing a thrombectomy procedure using an indigo system aspiration catheter 8 (cat8).During the procedure, a cat8 was advanced into a 8f sheath with no wire.Consequently, the cat8 became kinked upon advancing; therefore, the cat8 was removed and the procedure was completed using a new cat8.There was no report of an adverse effect to the patient.
 
Manufacturer Narrative
Occupation: health professional "yes"; physician.Reason for non-evaluation: the hospital disposed of the device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INDIGO SYSTEM ASPIRATION CATHETER 8
Type of Device
DXE
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key6464893
MDR Text Key71920561
Report Number3005168196-2017-00536
Device Sequence Number1
Product Code DXE
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K160533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/01/2005,03/07/2017
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 Physician
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 03/07/2017
Initial Date FDA Received04/06/2017
Supplement Dates Manufacturer Received04/06/2018
Supplement Dates FDA Received07/31/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-