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

Catalog Number	APP1
Medical Device Problem Codes	Device Operational Issue (2914); Pumping Problem (3016)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/18/2016
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: 3005168196-2016-00221.
Event or Problem Description
The patient was undergoing a microneurosurgery procedure using an apollo pump.During the procedure, the physician noticed that the apollo pump was not reaching its maximum power and fluctuated between -26 and -28 in/hg.The procedure was successfully completed using the same apollo pump.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
(b)(4).The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The customer kept the device.

• Brand Name: APOLLO PUMP
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5442703
• Report Number: 3005168196-2016-00183
• Device Sequence Number: 13514671
• 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: K132931
• 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): 01/18/2016

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/17/2016
• Supplement Report FDA Received Date: 06/23/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 65