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

Model Number CATRXKIT

Device Problems Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)

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

Event Date 10/08/2021

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure in the left anterior descending artery (lad) using an indigo system catrx aspiration catheter (catrx) and a non-penumbra guide catheter.During the procedure, the physician used the catrx to successfully complete three passes in the target vessel.The catrx was then flushed.While re-advancing the catrx towards the target vessel to make the fourth pass, resistance was encountered and the catrx became stuck.Therefore, contrast imaging was performed.However, contrast began leaking onto the patient outside the guide catheter and the physician noticed a break as well as kinking in the catrx at the proximal end.Therefore, the catrx was removed.The procedure was completed using another catrx and the same guide catheter.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned catrx confirmed the device was fractured.Further evaluation revealed kinks on both sides of the fracture.If the device is forcefully advanced against resistance, damage such as kinks may occur.Subsequently, if the device is further manipulated against resistance, the kink may worsen to a fracture.The root cause of resistance during the procedure could not be determined.Further evaluation of the catrx revealed additional bends on the distal fractured segment.This damage is likely incidental to the reported 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.

• 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: 12755676
• MDR Text Key: 284643678
• Report Number: 3005168196-2021-02493
• Device Sequence Number: 1
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• 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
• Report Date: 01/01/2005,11/04/2021

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 Expiration Date: 05/10/2024
• Device Model Number: CATRXKIT
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F106139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2021
• 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: 10/08/2021
• Initial Date FDA Received: 11/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2021
• 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: 49 YR
• Patient Sex: Male