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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
Model Number CAT6KIT-A
Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/27/2020
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
The patient was undergoing a medical procedure using an indigo system aspiration catheter 6 (cat6).During the procedure, while advancing the cat6 into the sheath, the physician experienced resistance and kinked the cat6 approximately three centimeters from the distal tip.Therefore, the cat6 was removed.The procedure was completed using a new cat6.There was no report of an adverse effect to the patient.
 
Event Description
The patient was undergoing a medical procedure using an indigo system aspiration catheter 6 (cat6) and non-penumbra sheath.During the procedure, while advancing the cat6 into the sheath, the physician experienced resistance and the cat6 became kinked approximately three centimeters from the distal tip.Therefore, the cat6 was removed.The procedure was completed using a new cat6 and the same sheath.There was no report of an adverse effect to the patient.
 
Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 01/15/2021: 1.Section b.Describe event or problem.H3 other text : placeholder.
 
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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
MDR Report Key11093480
MDR Text Key224247162
Report Number3005168196-2020-02381
Device Sequence Number1
Product Code DXE
UDI-Device Identifier00815948020405
UDI-Public00815948020405
Combination Product (y/n)Y
PMA/PMN Number
K160533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 01/01/2005,11/30/2020
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 Date10/16/2023
Device Model NumberCAT6KIT-A
Device Catalogue NumberCAT6KIT
Device Lot NumberF101197
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Date Report to Manufacturer01/10/2005
Initial Date Manufacturer Received 11/30/2020
Initial Date FDA Received12/30/2020
Supplement Dates Manufacturer Received01/15/2021
Supplement Dates FDA Received02/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age88 YR
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