MAUDE Adverse Event Report: PENUMBRA, INC. INDIGO PUMP MAX CANISTER; DXE

Catalog Number	IAPS2
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/20/2018
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 product lot number was not provided, therefore, the manufacturing records could not be reviewed.
Event or Problem Description
During preparation for a thrombectomy procedure, a penumbra system aspiration pump max 110 (pump max) was unable to achieve full vacuum.The hospital staff checked all the connections, however, the pump max was still unable to achieve full vacuum.Therefore, the indigo pump max canister (canister) was removed, and the procedure was successfully completed using a new canister.

• Brand Name: INDIGO PUMP MAX CANISTER
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8346092
• Report Number: 3005168196-2019-00286
• Device Sequence Number: 2034802
• Product Code: DXE
• UDI-Device Identifier: 00814548013343
• UDI-Public: 00814548013343
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 01/17/2019
• 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 Catalogue Number: IAPS2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 02/15/2019
• 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