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

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).

• 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 Key: 18871717
• MDR Text Key: 337292017
• Report Number: 3005168196-2024-00070
• Device Sequence Number: 1
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 814548017556
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220683
• Number of Events Reported: 1
• 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 Number: CATRXKIT
• Device Lot Number: F00008149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 02/17/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female