MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 3; DXE

Model Number SEP3-A

Device Problem Difficult to Advance (2920)

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

Event Date 04/21/2021

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.This report is associated with mfr report number: 3005168196-2021-01071.

Event Description

The patient was undergoing a thrombectomy procedure in the posterior tibial artery using an indigo system cat3 aspiration catheter (cat3), an indigo system separator 3 (sep3), and a guidewire.During the procedure, the physician advanced a cat3 to the target vessel and initiated aspiration.While aspirating, the physician noticed the cat3 was getting clogged up with thrombus.Therefore, the physician decided to use a sep3 to assist the cat3.However, while advancing the sep3 through the cat3, the physician noticed under fluoroscopy that the sep3 exited the side wall of the cat3 instead of the distal end; therefore, the cat3 and sep3 were removed.Upon removal of the cat3, the physician noticed that the lumen of the cat3 was punctured approximately a few inches proximal from the distal end.It was noted that the sep3 was removed intact.The procedure was completed with a lysis catheter.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM SEPARATOR 3
• Type of Device: DXE
• 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: 11842268
• MDR Text Key: 251197262
• Report Number: 3005168196-2021-01072
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016115
• UDI-Public: 00814548016115
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K160533
• 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: 01/01/2005,04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2021
• Device Model Number: SEP3-A
• Device Catalogue Number: SEP3
• Device Lot Number: F84143
• 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
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2018
• 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: 57 YR