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

Catalog Number	SEPD
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.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.The hospital disposed of the device.
Event or Problem Description
During preparation for a thrombectomy procedure on the back table, the indigo system separator d (sepd) was accidentally knocked off the table onto the floor.The sepd fell on the floor prior to use and therefore, it was not used in the procedure.The procedure was completed using an indigo system catd aspiration catheter (catd).
Additional Manufacturer Narrative
Pma: k161523.

• Brand Name: INDIGO SYSTEM SEPARATOR D
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7441941
• Report Number: 3005168196-2018-00791
• Device Sequence Number: 1092899
• Product Code: DXE
• UDI-Device Identifier: 00814548017600
• UDI-Public: 00814548017600
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K161523
• 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,Followup
• Report Date (Section B): 03/23/2018
• 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: 08/17/2020
• Device Catalogue Number: SEPD
• Device Lot Number: F78736
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 03/23/2018
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 04/18/2018
• Supplement Report FDA Received Date: 08/28/2018
• 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