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

Catalog Number AP9

Device Problems Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 06/07/2017

Event Type  malfunction  

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 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.

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
• Type of Device: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 6691748
• MDR Text Key: 79262560
• Report Number: 3005168196-2017-01097
• Device Sequence Number: 1
• Product Code: GWG
• UDI-Device Identifier: 00814548016344
• UDI-Public: 00814548016344
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2017
• 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