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

Model Number	SEP3-A
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11842268
• Report Number: 3005168196-2021-01072
• Device Sequence Number: 19747996
• Product Code: DXE
• UDI-Device Identifier: 00814548016115
• UDI-Public: 00814548016115
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K160533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/21/2021
• Report Date (Section F): 01/01/2005

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
• Operator of Device: 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
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2021
• Initial Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Date Report Sent to FDA: 01/01/2005