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

Catalog Number	APTUBE1
Medical Device Problem Codes	Leak/Splash (1354); Device Difficult to Setup or Prepare (1487); Use of Device Problem (1670)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/29/2016
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.
Event or Problem Description
During preparation for a microneurosurgery procedure, after connecting the apollo irrigation tubing to the apollo wand and activating the generator to flush the system, it was noticed that the irrigation tubing was leaking at the connection between the distal female luer lock and the distal male to male swivel luer connector.The physician tightened the connection and the leak was stopped.The procedure was completed using the same irrigation tubing.
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.
Additional Manufacturer Narrative
Please note that the following section was inadvertently missed on the initial mfr report and is being included on this follow-up #02 mfr report: 1.Expiration date.

• Brand Name: APOLLO IRRIGATION TUBING
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5464837
• Report Number: 3005168196-2016-00254
• Device Sequence Number: 13546896
• Product Code: GWG
• UDI-Device Identifier: 00814548013602
• UDI-Public: 00814548013602
• Combination Product (Y/N): Y
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 01/29/2016
• Report Date (Section F): 01/01/2005

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: 01/25/2018
• Device Catalogue Number: APTUBE1
• Device Lot Number: F62391
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/29/2016
• Supplement Date Received by Manufacturer: Not provided; 01/14/2005
• Initial Report FDA Received Date: 02/26/2016
• Supplement Report FDA Received Date: 03/07/2016; 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005