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

Catalog Number PMX110

Device Problems Decrease in Pressure (1490); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2016

Event Type  malfunction  

Manufacturer Narrative

Results: the penumbra system aspiration pump max 110v (pump max) vacuum regulator knob was loose.Upon further evaluation, corrosion was spotted in one of the pump max cylinders.Conclusions: evaluation of the device revealed the regulator knob was loose hindering the ability to regulate vacuum pressure.This type of damage may result from over-loosening the regulator knob to the point where it may back out from the regulator knob housing.Further evaluation revealed corrosion in one of the cylinders.Penumbra pumps are visually and functionally inspected during incoming quality inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

The patient was undergoing a thrombectomy procedure to treat an acute stage cerebral infarction using a penumbra system aspiration pump max 110v (pump max).During the procedure, the physician performed and completed the procedure by simultaneously using the pump max with a penumbra system 5max ace reperfusion catheter (5max ace) and a stent device.However, after the procedure, it was reported that the vacuum regulator knob appeared to be loose.The physician reported that the aspiration pressure seemed to be low during the procedure.Upon inspection, it was confirmed that the vacuum regulator knob was loose as reported and would not properly turn.It was also confirmed that the aspiration pressure would not increase as usual when the pump max was turned on.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V
• Type of Device: JCX
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 6141780
• MDR Text Key: 61360192
• Report Number: 3005168196-2016-01752
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/02/2016

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
• Device Operator: Physician
• Device Catalogue Number: PMX110
• Device Lot Number: F13929-05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2016
• Initial Date FDA Received: 12/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2014
• 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