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U.S. Department of Health and Human Services

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

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PENUMBRA, INC. INDIGO SYSTEM CAT RX ASPIRATION CATHETER; DXE Back to Search Results
Model Number CATRXKIT
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problem Death (1802)
Event Date 06/05/2020
Event Type  Death  
Manufacturer Narrative
Potential adverse events in the labeling with the indigo aspiration system include, but are not limited to, device malfunction, hematoma or hemorrhage at the site, inability to completely remove thrombus, peripheral thromboembolic events, emergent surgery, including death.Therefore, it was determined that the reported adverse events were anticipated complications.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 thrombectomy procedure in the right anterior tibial artery using an indigo system catrx aspiration catheter (catrx) and non-penumbra sheath (cook).During the procedure, the physician made a pass using the catrx and non-penumbra sheath.While attempting to remove the catrx for flushing, the catrx broke into two pieces and approximately 40 centimeters of the catrx distal end was left inside the patient.It was reported that the physician experienced resistance while removing the catrx after it had broken in two pieces.The physician then attempted to remove the broken distal end of the catrx using a snare device for approximately 60 minutes, but it was unsuccessful.The sheath was then removed and replaced with another non-penumbra sheath to complete the balloon angioplasty.Afterwards, the patient was sent to an intensive care unit with a femoral compression device placed on the left leg; however, the femoral compression device ended up clogging the patient¿s entire left leg.The following day, the surgeon performed a surgical intervention of the right leg to remove the broken piece of the catrx.Subsequently, the patient expired; however, the cause of death is unknown at this time.Furthermore, the relationship between the broken distal end of the catrx and death is unknown.
 
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Brand Name
INDIGO SYSTEM CAT RX ASPIRATION CATHETER
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 Key10204009
MDR Text Key196730573
Report Number3005168196-2020-00827
Device Sequence Number1
Product Code DXE
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 01/01/2005,06/05/2020
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 Expiration Date01/13/2023
Device Model NumberCATRXKIT
Device Catalogue NumberCATRXKIT
Device Lot NumberF95547
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 06/05/2020
Initial Date FDA Received06/26/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death; Required Intervention;
Patient Age86 YR
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