MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V; JCX

Catalog Number PMX220

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

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

Event Date 11/20/2015

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 using a penumbra system aspiration pump max 220v (pump max).During the procedure, the pump max did not produce any vacuum when the "on/off" switch was pushed.The procedure was completed with manual aspiration.

Manufacturer Narrative

On (b)(6) 2016, confirmation was received that there was no adverse effect to the patient.Result: there was no visible damage to the exterior of the penumbra system aspiration pump max (pump).The pump was powered on multiple times and functioned without an issue.The pump generated vacuum each time it was powered on.Conclusion: evaluation of the retuned device revealed that the pump was functional.The pump was powered on multiple times and the pump generated vacuum each time it was powered on.Therefore, the root cause of the complaint cannot be determined.The pumps are 100% functionally tested during incoming inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

Event Description

There was no adverse effect to the patient.

Manufacturer Narrative

Please note that this report was initially submitted on 06/01/2017; however, the submission failed because it was marked as follow-up #1 instead of follow-up #2.Additional investigation was performed on the returned device with results and conclusions as follows: results: the penumbra system aspiration pump max 220v (pump max) was opened by a penumbra investigator and corrosion was observed on the outlet piston crown.Conclusions: the observed corrosion likely prevented the pump from powering on.The seized piston likely became jarred loose in transit of the pump being returned to penumbra.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP MAX 220V
• 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: 5342432
• MDR Text Key: 35003101
• Report Number: 3005168196-2016-00004
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 00814548012698
• UDI-Public: 00814548012698
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: PMX220
• Device Lot Number: F15888-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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