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U.S. Department of Health and Human Services

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

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PENUMBRA, INC. INDIGO SYSTEM CATRX ASPIRATION CATHETER; QEX, QEW Back to Search Results
Catalog Number CATRXKIT
Device Problems Fracture (1260); Physical Resistance/Sticking (4012)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/16/2024
Event Type  Injury  
Event Description
The patient was undergoing a thrombectomy procedure in the tibioperoneal trunk (pt trunk) in the left leg using an indigo system catrx aspiration catheter (catrx), a non-penumbra sheath, and a guide wire.During the procedure, a guide wire and sheath were advanced to the target vessel.The physician then advanced a catrx through the sheath.While advancing, the physician was unable to visualize the catrx.Next the angiogram revealed that the catrx and sheath were in the abdominal aorta, and it was noted that the catrx was wrapped around the guide wire.The physician then attempted to retract the catrx and wire back into the sheath; however, resistance was met and the catrx would not retract.The physician then attempted to retract the guide wire; however, the same issue occurred.It was reported that the wire and cartx were knotted together.Subsequently, the catrx fractured at the rapid exchange location.The proximal end of the catrx was removed and the distal end of the catrx remained in the right iliac artery.A snare device was used to remove the fractured portion of the catrx from the patient.The procedure was completed with a cat6.
 
Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.
 
Manufacturer Narrative
Evaluation of the returned catrx confirmed that the catheter was fractured, and the guidewire lumen was damaged.If the catrx is retracted against resistance, damage such as a fracture may occur.The reported catrx wrapping around the guidewire likely contributed to resistance during the procedure.If the guidewire lumen is advanced past the distal tip of the guide sheath, damage such as this may occur.Further evaluation revealed multiple kinks and bends along the catheter shaft.This damage was incidental to the reported complaint.Multiple kinks may have occurred during the procedure.The bend along the catheter shaft likely occurred during packaging of the device for return to penumbra.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 in the tibioperoneal trunk (pt trunk) in the left leg using an indigo system catrx aspiration catheter (catrx), a non-penumbra sheath, and a guide wire.During the procedure, a guide wire and sheath were advanced to the target vessel.The physician then advanced a catrx through the sheath.While advancing, the physician was unable to visualize the catrx.Next the angiogram revealed that the catrx and sheath were in the abdominal aorta and it was noted that the catrx was wrapped around the guide wire.The physician then attempted to retract the catrx and wire back into the sheath; however, resistance was met and the catrx would not retract.The physician then attempted to retract the guide wire; however, the same issue occurred.It was reported that the wire was wrapped around the catrx.Subsequently, the catrx fractured at the rapid exchange location.The proximal end of the catrx was removed and the distal end of the catrx remained in the right iliac artery.A snare device was used to remove the fractured portion of the catrx from the patient.The procedure was completed with an indigo system aspiration catheter 6 (cat6).
 
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Brand Name
INDIGO SYSTEM CATRX 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 Key18871717
MDR Text Key337292017
Report Number3005168196-2024-00070
Device Sequence Number1
Product Code QEX
UDI-Device Identifier00814548017556
UDI-Public814548017556
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K220683
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/01/2005,03/27/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCATRXKIT
Device Lot NumberF00008149
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/23/2024
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 02/17/2024
Initial Date FDA Received03/08/2024
Supplement Dates Manufacturer Received02/28/2024
Supplement Dates FDA Received03/28/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2023
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 Outcome(s) Required Intervention;
Patient Age69 YR
Patient SexFemale
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