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

Catalog Number	AP9
Medical Device Problem Codes	Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/07/2017
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
During preparation for a micro neurosurgery, the hospital staff noticed that the apollo wand (wand) was not working properly upon attaching it to the apollo generator and testing the apollo system.It was reported that the wire within the wand was not activated when depressing the apollo generator foot pedal (foot pedal) on the apollo system.Therefore, the physician opened a new wand, tested it and used it to complete the procedure.
Additional Manufacturer Narrative
Results: the apollo wand (wand) was leaking where the tubing connects to the rotating hemostasis valve (rhv).Conclusions: evaluation of the returned device revealed that the wire inside the wand was activated when depressing the foot pedal on the apollo system.The wand was connected to an apollo system and powered on.The foot pedal to the apollo generator was depressed and vibration was observed.Therefore, the reported lack of vibration could not be confirmed.Further evaluation of the wand revealed a leak.During functional analysis, while attempting to aspirate and irrigate the wand, two leaks were observed where the tubings are connected to the rotating hemostasis valve (rhv).The root cause of these leaks could not be determined.Penumbra wands are visually inspected during in-process inspection and during quality inspection after manufacturing.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: APOLLO WAND
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6691748
• Report Number: 3005168196-2017-01097
• Device Sequence Number: 18843200
• Product Code: GWG
• UDI-Device Identifier: 00814548016344
• UDI-Public: 00814548016344
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K152699
• 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,Followup
• Report Date (Section B): 06/07/2017

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: 01/12/2018
• Device Catalogue Number: AP9
• Device Lot Number: F73737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2017
• Initial Date Received by Manufacturer: 06/07/2017
• Supplement Date Received by Manufacturer: 07/12/2017
• Initial Report FDA Received Date: 07/06/2017
• Supplement Report FDA Received Date: 08/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1