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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 Problem Material Deformation (2976)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/03/2020
Event Type  malfunction  
Manufacturer Narrative
Results: the cat6 was kinked approximately 125.0, and 132.0 thru 135.0 cm from the hub.The cat6 was ovalized approximately 105.0, and 126.0 thru 128.0 cm from the hub.Conclusions: evaluation of the returned cat6 confirmed that the catheter was kinked.If the cat6 is forcefully advanced against resistance, damage such as a kink may occur.During the functional test, resistance was encountered while attempting to advance the returned cat6 through a demonstration peel able sheath due to the distal kink, and the cat6 could not be advanced any further.Further evaluation of the returned cat6 revealed ovalization along the catheter shaft.This damage was likely incidental to the reported complaint.Penumbra catheters are visually inspected during in-process inspection and during quality inspection after manufacturing.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 thrombectomy procedure in the superficial femoral artery (sfa) using an indigo system aspiration catheter 6 (cat6) and a non-penumbra sheath.During the procedure, the physician removed the cat6 midway through the procedure to flush.Afterwards, while attempting to reinsert the cat6 into the sheath without the use of a guidewire, the physician kinked the cat6.Therefore, the cat6 was removed.The procedure was completed using a new cat6, a guidewire, and the same sheath.There was no report of an adverse effect to the patient.
 
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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 Key11090000
MDR Text Key226031115
Report Number3005168196-2020-02377
Device Sequence Number1
Product Code DXE
UDI-Device Identifier00815948020405
UDI-Public00815948020405
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 01/01/2005,12/03/2020
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 Date09/22/2023
Device Model NumberCAT6KIT-A
Device Catalogue NumberCAT6KIT
Device Lot NumberF100439
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/10/2020
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 12/03/2020
Initial Date FDA Received12/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age68 YR
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