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

Catalog Number PST2

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 01/30/2014

Event Type  malfunction  

Event Description

The patient was undergoing thrombectomy procedure in the internal carotid artery (ica) using the penumbra system max aspiration tubing.During the procedure while the physician was conducting aspiration, blood leaked from the on-off switch on the pst2 and did not flow into a pump canister.Physician's comment: blood leaked from the slider on the aspiration tube.These devices were connected properly.I could not fix it.

Manufacturer Narrative

Result: the aspiration tubing on/off switch is cracked underneath the toggle switch.The 3-way stop cock (non-penumbra device) is cracked where the luer fitting connects to the stop cock.Conclusion: the device was returned for analysis and has been evaluated.The complaint indicates that there was a leak from the on/off switch that connected to the aspiration tubing.Evaluation of the returned product confirmed a crack in the aspiration tubing.In addition, aspiration from the tubing to the canister was confirmed however, the leaks in both the aspiration tubing and crack in the non-penumbra 3-way stop cock prevented efficient aspiration into the system.The crack in the aspiration tubing is of unknown origin.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 3005168196-2014-00181.

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

• Brand Name: PENUMBRA SYSTEM MAX ASPIRATION TUBING
• Type of Device: 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: 3654264
• MDR Text Key: 4317931
• Report Number: 3005168196-2014-00142
• Device Sequence Number: 1
• Product Code: JCX
• 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: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2014

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 Expiration Date: 10/31/2016
• Device Catalogue Number: PST2
• Device Lot Number: F38997
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2014
• Initial Date FDA Received: 03/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2013
• 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