MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 4; QEX, QEW

Model Number SEPC4

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

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

Event Date 10/13/2021

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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 left peroneal artery, left anterior tibial artery and posterior tibial artery using an indigo system separator 4 (sep4), an indigo system catrx aspiration catheter (catrx), a non-penumbra sheath and a guidewire.During the procedure, the physician successfully revascularized the left peroneal artery by using the catrx and the sep4.Afterwards, the physician advanced the catrx to the left anterior tibial artery with the help of a guidewire and advanced the sep4 through the catrx.The physician encountered resistance as the sep4 was being advanced 1-2 cm past the distal end of the catrx due to significant chronic thrombus in the vessel.After completing a few passes, the physician noticed that the sep4 bulb was not moving along with its pusher wire.He then suctioned the sep4 bulb to the tip of the catrx.He retracted the catrx with aspiration turned on and was able to remove the sep4 and the bulb completely from the patient's vessel.The procedure was completed using a new sep4 and the same catrx.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report 3005168196-2021-02528: section a.Box 1.Patient identifier h3 other text : placeholder.

• Brand Name: INDIGO SYSTEM SEPARATOR 4
• 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: 12782770
• MDR Text Key: 283090946
• Report Number: 3005168196-2021-02528
• Device Sequence Number: 1
• Product Code: QEX
• UDI-Device Identifier: 00814548017594
• UDI-Public: 00814548017594
• 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: 01/01/2005,01/21/2022

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: 09/30/2023
• Device Model Number: SEPC4
• Device Catalogue Number: SEPC4
• Device Lot Number: F100671
• Was Device Available for Evaluation?: No
• 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: 10/13/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 01/21/2022
• Supplement Dates FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• 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: 34 YR
• Patient Sex: Male