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

Catalog Number	SEP3
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.The reported complaint involves the sterility of a dropped device after removal from the packaging during the procedure.Sterility of a dropped device cannot be confirmed in the evaluation lab and does not involve manufacturing records; therefore, an investigation will not be performed.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using an indigo system separator 3 (sep3).While preparing a sep3 for use, the hospital technician inadvertently dropped the sep3 on the ground and, consequently, the sep3 was contaminated.The contamination of the sep3 occurred prior to use and, therefore, it was not used in the procedure.The procedure was then continued using a new sep3.

• Brand Name: INDIGO SYSTEM SEPARATOR 3
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8768045
• Report Number: 3005168196-2019-01322
• Device Sequence Number: 2038715
• Product Code: DXE
• UDI-Device Identifier: 00814548016115
• UDI-Public: 00814548016115
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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): 06/10/2019
• 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: 06/09/2019
• Device Catalogue Number: SEP3
• Device Lot Number: F70063
• 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: 06/10/2019
• Initial Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005