MAUDE Adverse Event Report: PENUMBRA, INC. APOLLO SYSTEM APOLLO WAND; GWG

Catalog Number AP9

Device Problems Leak/Splash (1354); Aspiration Issue (2883)

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

Event Date 10/06/2014

Event Type  malfunction  

Event Description

The patient was undergoing a microneurosurgery using an apollo system apollo wand.During the procedure, the apollo wand was unable to aspirate well and a leak was observed at the connection between the tubing and the pump.The apollo wand was removed and the procedure continued using another apollo wand.

Manufacturer Narrative

Result: the apollo wand was leaking where the catheter knob connects to the generator.Conclusion: the complaint has been evaluated.The complaint indicates that the apollo wand leaked where the catheter knob attaches to the generator.Evaluation of the returned devices confirmed that the apollo wand leaked at the location described in the complaint.Based on the description of the event and evaluation of the returned device, it appears that the connection between the catheter knob and the generator did not seal properly, however the root cause of this issue could not be determined.There was no visible damage to the interior or exterior of the catheter knob.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: APOLLO SYSTEM APOLLO WAND
• Type of Device: GWG
• 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: 4228761
• MDR Text Key: 5072703
• Report Number: 3005168196-2014-00777
• Device Sequence Number: 1
• Product Code: GWG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 06/30/2015
• Device Catalogue Number: AP9
• Device Lot Number: F43966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2014
• 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