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

Catalog Number	AP9
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a microneurosurgery procedure using an apollo wand (wand).During the procedure, the sonicator wire inside the wand came out of the tip of the wand.Therefore, the wand was removed and the procedure was completed using a new wand.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: the sonicator wire was extending out the distal tip of the apollo wand (wand), and was not visible through the rotating hemostasis valve (rhv) on the proximal end of the wand tubing.The acrylonitrile butadiene styrene (abs) connector housing on the proximal end of the wand tubing was slightly melted.The sonic connector was removed from the abs housing by the penumbra investigator, and it was observed that the sonicator wire was fractured right inside the sonic connector.Conclusion: evaluation of the returned device revealed that the sonicator wire was fractured on the proximal end of the wand tubing.Further evaluation revealed that the abs connector housing was slightly melted.Extended use of the wand could cause heat to build up at the sonic connector, which may contribute to the abs connector housing melting and sonicator wire fatigue.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 WAND
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5610330
• Report Number: 3005168196-2016-00523
• Device Sequence Number: 10853378
• Product Code: GWG
• UDI-Device Identifier: 00814548013589
• UDI-Public: 00814548013589
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/28/2016

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: Physician
• Device Expiration Date: 08/23/2016
• Device Catalogue Number: AP9
• Device Lot Number: F65452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/28/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/26/2016
• Supplement Report FDA Received Date: 06/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR