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

Catalog Number PMX110

Device Problems Device Operates Differently Than Expected (2913); Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2016

Event Type  malfunction  

Manufacturer Narrative

Results: the penumbra system aspiration pump max 110v (pump max) was plugged in and powered on and functioned as intended.The pump max was power cycled 10 times and no issues were found with the pump or the power button.Conclusions: evaluation of the returned device revealed that the 3max was kinked and fractured.This type of damage likely occurs due to improper handling during removal from the packaging.If the device is forcefully removed from the packaging hoop at an angle, damage such as this may occur.Evaluation of the returned pump max revealed that the pump was functional.The pump was plugged in and power cycled 10 times using the power button, and no issues were found.The 3maxc devices are 100% visually inspected during in-process.Pumps are 100% 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 number: 3005168196-2016-00782.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system 3max reperfusion catheter (3max) and a penumbra system aspiration pump max 110v (pump max).During preparation for the procedure, the hospital staff noticed that the 3max was kinked upon removal from the packaging.The kinked 3max was found prior to use and therefore, was not used for the procedure.A new 3max was then opened for the procedure.During the procedure, the pump max "on/off" switch was intermittently not working.However, the procedure was completed using the second 3max and the same pump max.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: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5717731
• MDR Text Key: 47219558
• Report Number: 3005168196-2016-00783
• 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: 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PMX110
• Device Lot Number: F06601-27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/26/2012
• 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