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

Catalog Number SEP3

Device Problem Device Handling Problem (3265)

Patient Problem No Patient Involvement (2645)

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

The product was disposed of by the hospital and is no longer available for return.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: 3005168196-2018-00895.

Event Description

During preparation for a thrombectomy procedure, the indigo system cat3 aspiration catheter (cat3) and indigo system separator 3 (sep3) were accidentally dropped on the floor and became contaminated upon removal from the packaging.The cat3 and the sep3 were dropped prior to use.Therefore, they were not used in the procedure.The procedure was completed using new cat3 and sep3 devices.

• 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: 7473971
• MDR Text Key: 106970470
• Report Number: 3005168196-2018-00896
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548016115
• UDI-Public: 00814548016115
• Combination Product (y/n): N
• 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: 04/03/2018

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: 07/21/2019
• Device Catalogue Number: SEP3
• Device Lot Number: F70767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2018
• Initial Date FDA Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2016
• 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