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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 Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/26/2024
Event Type  malfunction  
Event Description
The patient was undergoing a thrombectomy procedure in the anterior tibial artery using an indigo system catrx aspiration catheter (catrx), indigo system aspiration catheter 7 (cat7), a non-penumbra sheath, and a guidewire.During the procedure, the physician used a cat7 and sheath to successfully clear off as much thrombus from the aneurysm section of a bypass that the patient had on the leg from previous popliteal entrapment syndrome.The physician then removed the cat7 and advanced the catrx using the sheath to the anterior tibial and completed two passes.Since the target vessel was heavily thrombosed, the physician decided to remove the catrx as access to the target vessel was challenging.While retracting the catrx, the physician experienced resistance at the distal end of the sheath and noticed that the catrx was stuck in the patient''s thigh.The physician then pulled the catrx back harder and observed under fluoroscopy that the radio marker of the catrx was still visible on the screen and not moving as the rest of the catrx was being removed.It was reported that the rapid exchange lumen of the catrx had fractured.The physician used a snare device to successfully remove the fractured segment of the catrx.The procedure ended at this point since vessel access was challenging.
 
Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
 
Event Description
The patient was undergoing a thrombectomy procedure in the anterior tibial artery using an indigo system catrx aspiration catheter (catrx), indigo system aspiration catheter 7 (cat7), a non-penumbra sheath, and a guidewire.During the procedure, the physician used a cat7 and sheath to successfully clear off as much thrombus from the aneurysm section of a bypass that the patient had on the leg from previous popliteal entrapment syndrome.The physician then removed the cat7 and advanced the catrx using the sheath to the anterior tibial and completed two passes.Since the target vessel was heavily thrombosed, the physician decided to remove the catrx as access to the target vessel was challenging.While retracting the catrx, the physician experienced resistance at the distal end of the sheath and noticed that the catrx was stuck in the patient''s thigh.The physician then pulled the catrx back harder and observed under fluoroscopy that the radio marker of the catrx was still visible on the screen and not moving as the rest of the catrx was being removed.It was reported that the catrx fractured at the rapid exchange lumen.The physician used a snare device to successfully remove the fractured segment of the catrx.The procedure ended at this point since vessel access was challenging.There was no report of an adverse effect to the patient.
 
Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report: 3005168196-2024-00112.1.Section b.Box 1.Adverse event and/or product problem 2.Section b.Box 5.Describe event or problem 3.Section h.Box 1.Type of reportable event 4.Section h.Box 6.Patient code 1.Evaluation of the returned catrx confirmed that the catheter was fractured.Evaluation revealed a kink and stretching near the fractured location.If the catrx was advanced against resistance, damage such as a kink may occur.If the proximal end of the guidewire lumen is advanced beyond the distal tip of the non-penumbra sheath, the guidewire may buckle and resistance may be experienced upon retraction.Forceful retraction against this resistance may result in stretching and a subsequent fracture.Further evaluation revealed additional kinks along the catheter shaft.This damage was incidental to the reported complaint and may have occurred during packaging of the device for return.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.H3 other text : placeholder.
 
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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 Key18985782
MDR Text Key338693313
Report Number3005168196-2024-00112
Device Sequence Number1
Product Code QEX
UDI-Device Identifier00815948025448
UDI-Public815948025448
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K220683
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/01/2005,05/12/2024
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 NumberC00012951
Was Device Available for Evaluation? Device Returned to Manufacturer
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 02/26/2024
Initial Date FDA Received03/27/2024
Supplement Dates Manufacturer Received04/12/2024
Supplement Dates FDA Received05/13/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/02/2023
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;
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