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

Catalog Number PMX110

Device Problems Aspiration Issue (2883); Device Operational Issue (2914); No Pressure (2994)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/07/2015

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 in the femoral artery using a penumbra system aspiration pump max 110 (pump max).During the procedure, the physician inserted a penumbra system 3max reperfusion catheter (3max) and switched on the pump max to begin aspiration of the thrombus.However, the physician was unable to confirm if any vacuum was being produced and noticed that only the fan was on.The procedure was successfully completed using a syringe.

Manufacturer Narrative

Result: there was no visible damage to the penumbra aspiration pump max 110 (pump).The pump was power cycled repeatedly and achieved fully adjustable vacuum each cycle.Conclusion: evaluation of the returned device revealed it was fully functional.The root cause of the complaint could not be determined.These 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 110
• 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: 5189975
• MDR Text Key: 29918947
• Report Number: 3005168196-2015-01114
• 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,Followup
• Report Date: 10/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PMX110
• Device Lot Number: F14048-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2014
• 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
• Patient Age: 95 YR