MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO SYSTEM SEPARATOR 6; DXE

Catalog Number SEP6

Device Problem Device Fell (4014)

Patient Problem No Patient Involvement (2645)

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for evaluation.Furthermore, the reported complaint involves the sterility of a dropped device after removal from the packaging during preparation for 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

During preparation for a thrombectomy procedure, the indigo system separator 6 (sep6) was inadvertently dropped on the back table, and then rolled off and fell on the floor, upon opening of the packaging.The sep6 was dropped prior to use; therefore, the sep6 was not used in the procedure.The procedure was completed using a new sep6.

• Brand Name: INDIGO SYSTEM SEPARATOR 6
• 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: 8230902
• MDR Text Key: 132504057
• Report Number: 3005168196-2019-00036
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016146
• UDI-Public: 00814548016146
• 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: 01/01/2005,12/10/2018

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: 07/12/2021
• Device Catalogue Number: SEP6
• Device Lot Number: F84628
• 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: 12/10/2018
• Initial Date FDA Received: 01/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2018
• 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