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

Catalog Number CATRXKIT

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2023

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure in the tibioperoneal trunk using an indigo system catrx aspiration catheter (catrx) non-penumbra angiographic catheter and a non-penumbra sheath.During the procedure, the physician obtained access below the knee using an angiographic catheter.Next, the physician made two passes in the target location using the catrx and noticed there was no blood flow through the catrx.Therefore, the physician decided to remove catrx off the guidewire to be flushed.However, while retracting the catrx, the physician experienced resistance and broke the proximal end of the catrx.Therefore, the catrx was not used for the remainder of the procedure.Subsequently, the physician used a new catrx and made two additional passes in the vessel.However, the same issue had occurred, and the physician decided to remove the catrx to be flushed.While retracting, the physician experienced resistance and broke the proximal end of the catrx.Therefore, the catrx was not used for the remainder of the procedure.It was reported that the physician was done with aspirating in the tibioperoneal trunk at this point.The procedure was completed using a balloon catheter and a new sheath in the iliac and superficial femoral artery (sfa).There was no report of an adverse effect to the patient.

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.This report is associated with mfr report number: 1.3005168196-2023-00172 h3 other text : placeholder.

Manufacturer Narrative

Evaluation of the first returned catrx confirmed that the catheter was fractured on its proximal shaft and revealed kinks near the fracture.If the catrx is retracted against resistance at angles, the device may become kinked and subsequently fractured.The catrx was unable to be functionally tested due to the fracture.Therefore, the root cause of the reported aspiration issue could not be determined.Evaluation of the second returned catrx confirmed that the catheter was fractured on its proximal shaft and revealed kinks near the fracture.If the catrx is retracted against resistance at angles, the device may become kinked and subsequently fractured.The catrx was unable to be functionally tested due to the fracture.Therefore, the root cause of the reported aspiration issue could not be determined.Further evaluation of the device revealed an additional kink on the catheter shaft and the guidewire lumen was damaged on its proximal end and distal end.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.This report is associated with mfr report number: 1.3005168196-2023-00172 h3 other text : placeholder.

• 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: 16758559
• MDR Text Key: 313711952
• Report Number: 3005168196-2023-00171
• 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: K163618
• 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: 01/01/2005,05/04/2023

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 Catalogue Number: CATRXKIT
• Device Lot Number: F00002575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• 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: 03/24/2023
• Initial Date FDA Received: 04/17/2023
• Supplement Dates Manufacturer Received: 04/17/2023
• Supplement Dates FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2022
• 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 Age: 52 YR
• Patient Sex: Female