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

Catalog Number	AP9
Medical Device Problem Codes	Leak/Splash (1354); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: there was a leak at the connection between the apollo wand and the transducer housing.Conclusions: evaluation of the returned device revealed that the wand was nonfunctional.The wand was connected to a demonstration apollo system to be functionally tested, and a leak was observed.The root cause of this complaint could not be determined.All wands are visually inspected during in-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, the physician noticed the apollo wand (wand) was leaking from the hub.The damaged wand was noticed prior to use in the patient and therefore, was not used in the procedure.The procedure was completed using a new wand.

• Brand Name: APOLLO WAND, LONG
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6094823
• Report Number: 3005168196-2016-01602
• Device Sequence Number: 2102565
• 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
• Report Date (Section B): 10/14/2016

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: 02/25/2017
• Device Catalogue Number: AP9
• Device Lot Number: F68088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2016
• Initial Report FDA Received Date: 11/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1