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

Model Number CATRXKIT

Device Problems Break (1069); Failure to Advance (2524); Physical Resistance/Sticking (4012)

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

Event Date 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the returned catrx confirmed a fracture on the distal shaft.If the device is forcefully retracted against resistance, damage such as this may occur.Further evaluation revealed that a non-penumbra guidewire was returned inside the guidewire lumen of the catrx distal fractured segment, the guidewire was protruding through the middle of the fractured segment, and the catrx was damaged at the protruding location.The cause of this damage could not be determined; however, this damage may have contributed to the catrx becoming stuck during the procedure and may have caused resistance during retraction.Further evaluation revealed a kink on the catrx distal tip, and the non-penumbra guidewires were cut on their ends.This damage was 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.

Event Description

The patient was undergoing a thrombectomy procedure in the right coronary artery using an indigo system catrx aspiration catheter (catrx), a non-penumbra sheath, and a coronary guidewire.During the procedure, the physician successfully completed two passes using the catrx and guidewire.While advancing the catrx over the guidewire through the guidewire lumen for the final pass, the catrx became stuck and would not advance any further.Subsequently, the physician decided to retract the catrx.While retracting the catrx off the guidewire, the physician pulled the catrx with force and broke the catrx at the distal end outside of the patient¿s body.Therefore, the catrx was removed.The procedure was completed using a new catrx and a new guidewire.There was no report of an adverse effect to the patient.

• 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: 12510242
• MDR Text Key: 272686553
• Report Number: 3005168196-2021-02102
• Device Sequence Number: 1
• Product Code: QEX
• UDI-Device Identifier: 00814548017556
• UDI-Public: 00814548017556
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K163618
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,09/21/2021

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: 04/12/2024
• Device Model Number: CATRXKIT
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F105353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• 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: 08/26/2021
• Initial Date FDA Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2021
• 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