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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM CAT RX ASPIRATION CATHETER; QEX, QEW

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PENUMBRA, INC. INDIGO SYSTEM CAT RX ASPIRATION CATHETER; QEX, QEW Back to Search Results
Model Number CATRXKIT
Device Problems Difficult to Remove (1528); Failure to Advance (2524); Physical Resistance/Sticking (4012)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Results: the catrx was kinked approximately 141.0 cm from the hub.The guidewire lumen was damaged from its proximal end to approximately 14.0 cm from the distal tip.Conclusions: evaluation of the returned catrx revealed that the guidewire lumen was damaged.If the catrx and guidewire are forcefully mishandled at extreme angles while the guidewire is inside the guidewire lumen, the guidewire lumen may become damaged.If the guidewire lumen is damaged and the guidewire is outside the guidewire lumen, resistance may be encountered while advancing the device.During functional testing, the catrx was unable to advance through a demonstration benchmark with the guidewire inserted through the guidewire lumen.The guidewire was able to be removed from the catrx without issue.Further evaluation of the device revealed kink near its distal tip.This damage was likely incidental to the complaint.Penumbra catheters are 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 using an indigo system catrx aspiration catheter (catrx).During the procedure, the catrx was unable to be advanced over a guidewire and became stuck.Subsequently, the catrx was unable to be removed from the guidewire.It was also reported that upon inspection, the guidewire had punctured the side of the catrx while attempting to load the guidewire into the exchange port.It is unknown how the procedure was completed.There was no report of an adverse effect to the patient.
 
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Brand Name
INDIGO SYSTEM CAT RX ASPIRATION CATHETER
Type of Device
QEX, QEW
Manufacturer (Section D)
PENUMBRA, INC.
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
5107483200
MDR Report Key10848808
MDR Text Key216949902
Report Number3005168196-2020-02011
Device Sequence Number1
Product Code QEX
UDI-Device Identifier00814548017556
UDI-Public00814548017556
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K163618
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 01/01/2005,10/22/2020
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 Date05/07/2023
Device Model NumberCATRXKIT
Device Catalogue NumberCATRXKIT
Device Lot NumberF97744
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2020
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 10/22/2020
Initial Date FDA Received11/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/07/2020
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 Age64 YR
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