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

Catalog Number	AP9
Medical Device Problem Codes	Material Integrity Problem (2978); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: there was no visible damage to the exterior of the apollo wand (wand).The sonicator wire of the wand was fractured approximately 43.0 cm from the distal tip.Conclusions: evaluation of the returned device revealed that the sonicator wire was fractured off.The root cause of this fracture could not 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.
Event or Problem Description
During preparation for a microneurosurgery procedure, while cleaning the tip of an apollo wand (wand), the hospital staff noticed that the agitator wire became loose and was pulled out.The damaged wand was found prior to use and was not used for the procedure.The procedure was completed using a new wand.

• Brand Name: APOLLO WAND
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5524573
• Report Number: 3005168196-2016-00363
• Device Sequence Number: 16227744
• Product Code: GWG
• UDI-Device Identifier: 00814548013589
• UDI-Public: 00814548013589
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K132931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2016
• Device Catalogue Number: AP9
• Device Lot Number: F65303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2016
• Initial Report FDA Received Date: 03/24/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1