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

Catalog Number PMX110

Device Problems Aspiration Issue (2883); Device Operates Differently Than Expected (2913); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2017

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 to treat a deep vein thrombosis (dvt) using a penumbra system aspiration pump max 110v (pump max).During the procedure, the pump max was unable to produce an aspiration level greater than -26 in/hg; however, the procedure was completed using the same pump max.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: the regulator knob was taped to the penumbra system aspiration pump max 110v (pump max) housing.The pump max vacuum gauge was capable of reaching -28 in/hg.The calibrated gauge shows the vacuum gauge reaching -27 in/hg.Conclusions: evaluation of the returned device revealed that the pump max was capable of reaching an aspiration level greater than -26 in/hg.During functional analysis, the tape was removed from the regulator knob, and the pump max was plugged in and powered on.The vacuum pressure was adjusted using the regulator knob and the pump max was capable of reaching -28 in/hg and -27 in/hg with a calibrated gauge.Therefore, the pump max was within specification and deemed functional.The root cause of the low aspiration level reported during the procedure could not be determined.Penumbra pumps are 100% functionally tested during incoming inspection by quality.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V
• Type of Device: DXE
• 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: 6622427
• MDR Text Key: 77007266
• Report Number: 3005168196-2017-00888
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00814548012773
• UDI-Public: 00814548012773
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160533
• 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,Followup
• Report Date: 05/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PMX110
• Device Lot Number: F12110-35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2014
• 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
• Patient Age: 32 YR
• Patient Weight: 133