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

Catalog Number AP9

Device Problem Aspiration Issue (2883)

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

Event Date 11/18/2014

Event Type  malfunction  

Event Description

The patient was undergoing a microneurosurgery procedure using an apollo wand.During the procedure, the physician aspirated approximately 600 ml with the apollo wand and as the physician pulled the wand out of a 8f sheath, it was noted that the wire was extending out of the bottom of the wand and would no longer aspirate.A new apollo wand was used to complete the procedure.There was no report of an adverse effect on the patient.

Manufacturer Narrative

Conclusion: the device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Manufacturer Narrative

Result: there was no visible damage to the exterior of the wand.The wand sonic wire was fractured approximately 45.0 cm distal tip.Conclusion: the complaint has been evaluated.The complaint indicated that the wand was used to aspirate 600 ml then removed from the 8f sheath.The physician noticed the wire was extending out of the distal end, and that the wand would not aspirate.Evaluation of the returned device revealed that the sonic wire was fractured and the wand would not vibrate, aspirate, or irrigate.The sonic wire is a continuous length of wire.The cause of the fractured sonic wire inside the wand is unknown; however, the fractured sonic wire prevented the wand from vibrating during the procedure.This allowed blood to clot inside the lumen and stop the wand from aspirating and irrigating.The root cause of this complaint cannot be determined.These devices are 100% visually inspected for damage during process inspection.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: 4343065
• MDR Text Key: 5215371
• Report Number: 3005168196-2014-00870
• 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,Followup
• Report Date: 11/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• 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: F43000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2014
• 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: 59 YR