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

Model Number PMX110

Device Problem Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2019

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 110 (pump max).During the procedure, it was reported that the pump max did not sound ¿normal¿.The physician switched the pump max canister (canister) for a new canister and the pump max continued to make a ¿funny noise¿.Despite the abnormal noise, the procedure was completed using the same pump max.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section was inadvertently missed on the initial mfr report and is being included on this follow-up #01 mfr report: serial #.Results: the pump was able to power on and produce a vacuum pressure of approximately -29.0 inhg.The demonstration canister was connected to the pump max vacuum inlet and pump was kept on running for approximately 30 minutes.No unusual sound was observed.Conclusions: evaluation of the returned pump max revealed a fully functional device.During functional testing, the pump max was run continuously for approximately 30 minutes with the demonstration canister connected and no unusual noise was observed.The reported noise could not be confirmed.Pump max was able to produce a vacuum pressure within the specification.Penumbra pumps are 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.

Manufacturer Narrative

Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #02 mfr report:3005168196-2019-00425.1.Section h.Box 5.Labeled for single use? 2.Section h.Box 8.Usage of device.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8401058
• MDR Text Key: 138211001
• Report Number: 3005168196-2019-00425
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): Y
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PMX110
• Device Catalogue Number: PMX110
• Device Lot Number: F40352-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 37 YR