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

Catalog Number	AP9
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2016
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
The patient was undergoing a microneurosurgery using an apollo wand (wand).During the procedure, the wand became clogged.Therefore, the wand was removed and the procedure continued using a new wand.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Result: there was no visible damage to the apollo wand (wand).The wand was connected, without an issue, to a demonstration apollo system and tested.The wand was able to irrigate and vibrate, but not aspirate.Conclusion: evaluation of the returned device confirmed that the wand was clogged.This type of problem typically occurs when the device is used without vibration and irrigation.If attempts were made during the procedure to remove clots using aspiration only, and foregoing the use of vibration and irrigation, it is likely that clogging would occur.The apollo wand is 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: 5791453
• Report Number: 3005168196-2016-00980
• Device Sequence Number: 11104186
• Product Code: GWG
• UDI-Device Identifier: 00814548013589
• UDI-Public: 00814548013589
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2016

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: 11/03/2016
• Device Catalogue Number: AP9
• Device Lot Number: F66255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/13/2016
• Supplement Report FDA Received Date: 08/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR