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

Catalog Number PAP110

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 07/15/2014

Event Type  malfunction  

Event Description

The patient was undergoing a thrombectomy procedure using a penumbra system aspiration pump 110.Prior to aspiration, the penumbra system aspiration pump 110 was turned on, however the gauge did not indicate that vacuum had been achieved.A new penumbra system aspiration pump 110 was used, and the gauge still did not function.The physician used the penumbra system aspiration pump 110 because it had normal vacuum power and aspiration was successful.

Manufacturer Narrative

Conclusion: this device is not available for return.However, a follow up mdr will be submitted upon completion of the device investigation based on photographs that were provided to the manufacturer.Device is not returning.

Manufacturer Narrative

Result: the penumbra aspiration pump had black residue coming from the back of the vacuum regulators.Conclusion: the compliant has been evaluated.The complaint indicates that the regulator gauges were clogged with black mud.Based on the images in the complaint, it appears that there was some type of black unknown material on the back of the penumbra aspiration pump regulators.The unknown material could be some kind of build-up from wear and tear over the years of usage or dried blood/clot.This can happen if the aspiration tubing is hooked up directly to the pump.Due to the pump not returning for evaluation, we are unable to conduct a material analysis on the black material, therefore, there is no way identifying what this material is.The root cause of this complaint cannot be determined.The pap110 are manufactured by an outsource company.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This mdr is associated with mdr 3005168196-2014-00723.

• Brand Name: PENUMBRA SYSTEM ASPIRATION PUMP 110
• Type of Device: BTA, JCX
• Manufacturer (Section D): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; 1351 harbor bay parkway; alameda CA 94502
• Manufacturer Contact: kathleen kidd ; 1351 harbor bay parkway; alameda, CA 94502 ; 5107483200
• MDR Report Key: 4181876
• MDR Text Key: 5021611
• Report Number: 3005168196-2014-00724
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K051758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2014

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: Physician
• Device Catalogue Number: PAP110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2015
• Initial Date FDA Received: 10/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1