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

Catalog Number	SEP3
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/03/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7473971
• Report Number: 3005168196-2018-00896
• Device Sequence Number: 128765
• Product Code: DXE
• UDI-Device Identifier: 00814548016115
• UDI-Public: 00814548016115
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 04/03/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/21/2019
• Device Catalogue Number: SEP3
• Device Lot Number: F70767
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2018
• Initial Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1