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

Catalog Number AP9

Device Problems Complete Blockage (1094); Leak/Splash (1354); Aspiration Issue (2883)

Patient Problem No Information (3190)

Event Date 07/14/2014

Event Type  malfunction  

Event Description

The patient was undergoing a microneurosurgery procedure using the apollo system apollo wand.During the procedure, the apollo wand became clogged and was unable to aspirate clot.The physician covered the tip of the apollo wand to determine if aspiration was occurring and found that it was not aspirating despite the pump working as intended.A new apollo wand was used to complete the procedure and removed a significant volume of clot.Following the procedure, it was noticed that the new apollo wand developed a leak at the plastic y adaptor connecting to the hard black transducer.

Manufacturer Narrative

Result: there is no visible damage to the catheter.Conclusion: the complaint has been evaluated.The complaint indicates that there was no aspiration coming from the apollo catheter/wand.During the evaluation of the returned device, the apollo catheter/wand was flushed with cavicide disinfectant solution.A piece of blood clot was observed in the cavicide disinfectant effluent.The apollo catheter/wand was subsequently tested for aspiration, irrigation, and vibration.The catheter/wand functioned without an issue.It is likely that the flushed clot could have led to this complaint.Once the clot was removed the apollo catheter/wand was functional.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 3005168196-2014-00537.

• 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: 4006781
• MDR Text Key: 20976022
• Report Number: 3005168196-2014-00536
• 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: 07/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/30/2015
• Device Catalogue Number: AP9
• Device Lot Number: F42783
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2014
• 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
• Patient Age: 44 YR