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

Catalog Number PMX110

Device Problems Aspiration Issue (2883); Device Operates Differently Than Expected (2913); No Pressure (2994)

Patient Problem No Patient Involvement (2645)

Event Date 12/28/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the regulator knob tubing of the penumbra system aspiration pump max 110v (pump max) was kinked.Conclusions: evaluation of the returned device revealed that the pump max gauge or the calibrated gauge would not decrease or increase when the regulator knob was adjusted.The pump max housing was opened by the penumbra investigator and it was observed that the regulator knob tubing was kinked.This damage likely occurred due to overtightening of the regulator knob while adjusting the vacuum pressure.The kink in the tubing was removed by the penumbra investigator and the pump max was powered on.The gauge on the pump and the calibrated gauge were able to be increased and decreased using the regulator knob.The kink in the tubing likely prevented the pump max vacuum pressure from being adjusted during the preparation for the procedure.The pump max was plugged in and powered on and the vacuum gauge did not increase or decrease using the regulator knob while attempting to be adjusted during the functional test.Penumbra pumps are 100% functionally tested during coming inspection by quality.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

During preparation for a thrombectomy procedure, the hospital technician noticed that the penumbra system aspiration pump max 110 (pump max) was unable to produce vacuum, despite the regulator gauge being turned up and the gauge showing full power.The inability of the pump max to produce vacuum was noticed prior to use, and therefore the pump max was not used in the procedure.The procedure was therefore completed using a new pump max.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 7220366
• MDR Text Key: 98429299
• Report Number: 3005168196-2018-00209
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PMX110
• Device Lot Number: F15336-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1