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

Catalog Number	APP1
Medical Device Problem Codes	Aspiration Issue (2883); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2016
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.This report is associated with mfr report number: 3005168196-2016-01891.
Event or Problem Description
The patient was undergoing a microneurosurgery procedure to treat an intracerebral hemorrhage (ich) using the apollo system.During the procedure, the physician noticed that the apollo wand (wand) was leaking from the connection point to the apollo generator (generator) and also from the rotating hemostasis valve (rhv).Therefore, the physician switched to a new wand.It was also noticed that the regulator knob on the apollo pump (pump) was not working properly and just spun around without much effect on the aspiration power.However, the procedure was still completed using the same pump.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the serial # was inadvertently reported as the lot # on the initial mfr report and is being corrected on this follow up #1 mfr report.Results: there was no visible damage to the apollo pump (pump).Conclusions: evaluation of the returned device revealed that the wand¿s rotating hemostasis valve (rhv) was leaking.The wand was connected to an apollo generator (generator) and during irrigation, a leak at the rhv was observed.The root cause of this failure could not be determined.Further evaluation of the returned devices revealed that the pump was functional.The pump was plugged in and powered on.The pump vacuum was able to be increased and decreased using the regulator knob without an issue.Penumbra devices 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 PUMP
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6215857
• Report Number: 3005168196-2016-01892
• Device Sequence Number: 708615
• Product Code: GWG
• UDI-Device Identifier: 00814548012711
• UDI-Public: 00814548012711
• 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): 12/04/2016

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 Catalogue Number: APP1
• Device Lot Number: F62692
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/04/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2016
• Supplement Report FDA Received Date: 03/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR