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

Catalog Number PMX110

Device Problems Mechanical Problem (1384); Suction Problem (2170)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2018

Event Type  malfunction  

Manufacturer Narrative

Results: the regulator knob was loose and unable to turn the vacuum power up or down.The pump max was able to power on and produced a vacuum pressure of approximately -28.5 inhg.Conclusions: evaluation of the returned pump max confirmed a loose regulator knob.If the regulator knob is over rotated, the hex nut that secures the regulator knob to the device housing may loosen.If the regulator knob is loosened, difficulty regulating vacuum pressure may be experienced.During functional testing, the pump max was able to power on and produce a vacuum pressure within specification, but was unable to regulate vacuum pressure.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.

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump max 110 (pump max) to treat a superficial femoral artery (sfa) and popliteal arteries.During the procedure, the regulator knob on the pump max was loose and could not be turned.It was reported that, as a result, the pump max did not produce maximum aspiration.Despite this, the procedure was successfully completed using the same pump max and there was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110
• Type of Device: NRY
• 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: 8174514
• MDR Text Key: 130895080
• Report Number: 3005168196-2018-02453
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K160449
• 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: 01/01/2005,11/19/2018

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: Health Professional
• Device Catalogue Number: PMX110
• Device Lot Number: F25371-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1