MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 110; DXE

Catalog Number	PMX110
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report numbers: 3005168196-2019-01437, 3005168196-2019-01438, 3005168196-2019-01439, 3005168196-2019-01440.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the circumflex artery using an indigo system cat rx kit, an indigo pump max canister (canister), a pump max canister (canister), and a penumbra system aspiration pump max 110 (pump max).During the procedure, the physician advanced the indigo system catrx aspiration catheter (catrx) into the target vessel, connected the pump max and initiated the aspiration; however, no vacuum was produced.Therefore, the catrx and canister were removed.The physician then placed a new catrx and canister; however, the same issue occurred.Therefore, the system was removed.The procedure was completed using another thrombectomy device.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #3005168196-2019-01441 mfr report: 1.Section h.Box 5.Labeled for single use? 2.Section h.Box 8.Usage of device.Results: the pump max power inlet was loose.Conclusions: evaluation of the returned pump max revealed a functional device.During functional testing, the pump max was able to power on and achieve a vacuum pressure within specification.The reported complaint could not be confirmed.The two catrxs and two canisters were not returned for evaluation; therefore, the root cause of the reported complaint could not be determined.Further evaluation revealed a loose power inlet.This damage was likely incidental to the complaint.Penumbra pumps are 100% visually inspected and functionally tested during incoming quality inspection.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 numbers: 3005168196-2019-01437; 3005168196-2019-01438; 3005168196-2019-01439; 3005168196-2019-01440.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110
• Common Device Name: DXE
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8826470
• Report Number: 3005168196-2019-01441
• Device Sequence Number: 19460536
• Product Code: DXE
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 06/25/2019
• 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: PMX110
• Device Lot Number: F26270-31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 09/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Date Report Sent to FDA: 01/01/2005