MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 5; DXE

Catalog Number	SEP5
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2019
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the femoral and common iliac arteries using an indigo system separator 5 (sep5).During the procedure, a clot began to build up in the indigo system cat5 aspiration catheter (cat5) and the physician decided to remove the cat5 and sep5 together.The cat5 was then flushed and re-advanced into the patient.Subsequently, the physician attempted to re-advance the sep5 into the cat5 through the tuohy valve and reported that the tip of the sep5 became kinked at the distal port of the tuohy valve.It was then discovered that the distal port of the tuohy valve had been accidentally left closed.The sep5 was therefore removed and was no longer used in the procedure.The procedure was completed using a new sep5 and the same cat5.There was no report of an adverse effect to the patient.

• Brand Name: INDIGO SYSTEM SEPARATOR 5
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8568584
• Report Number: 3005168196-2019-00839
• Device Sequence Number: 1836737
• Product Code: DXE
• UDI-Device Identifier: 00814548016108
• UDI-Public: 00814548016108
• Combination Product (Y/N): Y
• Initial Reporter State: AZ
• 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): 04/02/2019
• 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: 11/29/2021
• Device Catalogue Number: SEP5
• Device Lot Number: F87262
• 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: 04/02/2019
• Initial Report FDA Received Date: 05/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Date Report Sent to FDA: 01/01/2005