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

Model Number CATRXKIT

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Results: the catrx was kinked approximately 141.0 cm from the hub.The guidewire lumen was damaged from its proximal end to approximately 14.0 cm from the distal tip.Conclusions: evaluation of the returned catrx revealed that the guidewire lumen was damaged.If the catrx and guidewire are forcefully mishandled at extreme angles while the guidewire is inside the guidewire lumen, the guidewire lumen may become damaged.If the guidewire lumen is damaged and the guidewire is outside the guidewire lumen, resistance may be encountered while advancing the device.During functional testing, the catrx was unable to advance through a demonstration benchmark with the guidewire inserted through the guidewire lumen.The guidewire was able to be removed from the catrx without issue.Further evaluation of the device revealed kink near its distal tip.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.

Event Description

The patient was undergoing a thrombectomy procedure using an indigo system catrx aspiration catheter (catrx).During the procedure, the catrx was unable to be advanced over a guidewire and became stuck.Subsequently, the catrx was unable to be removed from the guidewire.It was also reported that upon inspection, the guidewire had punctured the side of the catrx while attempting to load the guidewire into the exchange port.It is unknown how the procedure was completed.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM CAT RX 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: 10848808
• MDR Text Key: 216949902
• Report Number: 3005168196-2020-02011
• 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: 01/01/2005,10/22/2020

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: 05/07/2023
• Device Model Number: CATRXKIT
• Device Catalogue Number: CATRXKIT
• Device Lot Number: F97744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• 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: 10/22/2020
• Initial Date FDA Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2020
• 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: 64 YR