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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6; DXE

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PENUMBRA, INC. INDIGO SYSTEM ASPIRATION CATHETER 6; DXE Back to Search Results
Catalog Number CAT6
Device Problems Device Damaged Prior to Use (2284); Material Deformation (2976)
Patient Problem No Patient Involvement (2645)
Event Date 01/15/2019
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.
 
Event Description
During preparation for a thrombectomy procedure, an indigo system aspiration catheter 6 (cat6) was found to be kinked in the shaft upon removal from the packaging.The damage to the cat6 was found prior to use and, therefore, the procedure was completed using a new cat6.
 
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Brand Name
INDIGO SYSTEM ASPIRATION CATHETER 6
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 Key8338154
MDR Text Key136118089
Report Number3005168196-2019-00255
Device Sequence Number1
Product Code DXE
UDI-Device Identifier00814548016245
UDI-Public00814548016245
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
Report Date 01/01/2005,01/15/2019
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 Health Professional
Device Expiration Date09/11/2021
Device Catalogue NumberCAT6
Device Lot NumberF85786
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 01/15/2019
Initial Date FDA Received02/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/12/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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