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

Catalog Number APTUBE1

Device Problems Leak/Splash (1354); Device Difficult to Setup or Prepare (1487); Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Date 01/29/2016

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.

Event 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.

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.

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
• Type of Device: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5464837
• MDR Text Key: 39206010
• Report Number: 3005168196-2016-00254
• Device Sequence Number: 1
• Product Code: GWG
• UDI-Device Identifier: 00814548013602
• UDI-Public: 00814548013602
• Combination Product (y/n): Y
• PMA/PMN Number: K132931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1