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

Catalog Number PMX110

Device Problems Device Operational Issue (2914); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2016

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 using a penumbra system aspiration pump max 110v (pump max).During the procedure, the physician advanced a penumbra system 5max ace reperfusion catheter (5max ace) into the patient and switched the pump max on in order to start aspirating thrombus.However, the physician could not confirm that any vacuum was being produced and turned off the pump max.After verifying that the tubing was properly connected, the physician restored the regulator knob and turned the pump max back on but no vacuum was produced.Therefore, the procedure was completed using a stent.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Results: there was no visible damage to the pump.The pump was plugged in and powered on.The pump only made a humming sound like a fan was running, and no vacuum was produced.The pump was opened by penumbra engineers and corrosion was observed on the piston crown in the outlet cylinder.Conclusions: evaluation of the returned device revealed the pump was nonfunctional.The pump was opened by penumbra engineers and corrosion was observed on the piston crown in the outlet cylinder.The observed corrosion likely caused the piston to seize inside the cylinder.The root cause of this corrosion could not be determined.Penumbra 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.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 110V
• 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: kathleen kidd ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 5520759
• MDR Text Key: 41026645
• Report Number: 3005168196-2016-00347
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PMX110
• Device Lot Number: F14222-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1