MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM PUMP CANISTER KIT; BTA, JCX

Catalog Number PAPS1

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/14/2014

Event Type  malfunction  

Event Description

During preparation for a procedure while using the penumbra system, the canister filter did not fix in the pump inlet due to a malfunction of the screw.The operation continued with another canister.

Manufacturer Narrative

Result: the device was not returned to penumbra.This investigation is based on photographs taken by the quality department at penumbra's distributor in (b)(4).The plastic threads on the pump canister filter screw are damaged.Conclusion: the complaint has been evaluated.The complaint indicates that the canister filter would not fix to the pump.Based on the photographs, it is likely that the filter might have been forced fitted to the pump, stripping the plastic screw threads.It is also possible that the filter screw threads were deformed due to a manufacturing defect.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SYSTEM PUMP CANISTER KIT
• 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: 3756781
• MDR Text Key: 4464382
• Report Number: 3005168196-2014-00235
• 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
• Report Date: 03/19/2014

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: PAPS1
• Device Lot Number: B000261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2014
• Initial Date FDA Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 93 YR