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

Catalog Number	APTUBE1
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a microneurosurgery procedure to treat a ventricular hemorrhage using the apollo system.During the procedure, the wand was making a lot of noise and seemed to not be working well.It was noted that the ventricular clot was thick and the wand did not seem to break it well and the aspiration seemed less than what was expected.The nurse then removed the apollo irrigation tubing (irrigation tubing) from the console and covered the aspiration port with a finger and noticed that the dial was at -20 inhg.When the irrigation tubing was connected back to the console, the aspiration pressure was at ¿25 inhg.It was reported that the wand also made a screeching high pitch noise; therefore, it was removed and a new wand was opened.The nurse then experienced difficulty while attempting to connect the irrigation tubing to the new wand and consequently, the irrigation tubing became contaminated.Therefore, the irrigation tubing was removed and a new irrigation tubing was opened.It was also noted that the protective cap (red with a wing shaped end) was very difficult to remove.After that, the procedure was completed with no complications and there was no report of an adverse effect to the patient.

• Brand Name: APOLLO IRRIGATION TUBING
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6149900
• Report Number: 3005168196-2016-01794
• Device Sequence Number: 376415
• Product Code: GWG
• UDI-Device Identifier: 00814548013602
• UDI-Public: 00814548013602
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2016

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: APTUBE1
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2016
• Initial Report FDA Received Date: 12/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR