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

Catalog Number SEP3

Device Problem Device Fell (4014)

Patient Problem No Patient Involvement (2645)

Event Date 06/07/2019

Event Type  malfunction  

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 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
• 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: 8768045
• MDR Text Key: 150286076
• Report Number: 3005168196-2019-01322
• 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: 01/01/2005,06/10/2019

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: 06/09/2019
• Device Catalogue Number: SEP3
• Device Lot Number: F70063
• 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: 06/10/2019
• Initial Date FDA Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2016
• 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