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

Catalog Number AP9

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 09/27/2017

Event Type  malfunction  

Manufacturer Narrative

Results: the apollo wand (wand) leaked at the connection between the apollo generator (generator) and the acrylonitrile butadiene styrene (abs) knob.Conclusions: evaluation of the returned device confirmed that the wand leaked.The wand was connected to an apollo system and was able to aspirate, irrigate, and vibrate; however, the wand leaked where the abs knob connects to the generator.The root cause of the leak could not be determined.Penumbra wands 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.

Event Description

During preparation for a microneurosurgery procedure, the physician noticed the apollo wand (wand) was leaking from the connection to the apollo generator.The damaged wand was noticed prior to use in the patient and therefore, was not used in the procedure.The procedure was completed using a new wand.

Manufacturer Narrative

Please note that section box 4.Device manufacture date was incorrectly reported on the initial mfr report and is being corrected on this follow-up # 1 mfr report.

• Brand Name: APOLLO WAND
• Type of Device: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 6976979
• MDR Text Key: 90904823
• Report Number: 3005168196-2017-01859
• Device Sequence Number: 1
• Product Code: GWG
• UDI-Device Identifier: 00814548016344
• UDI-Public: 00814548016344
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/27/2017

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
• Device Operator: Physician
• Device Expiration Date: 04/20/2018
• Device Catalogue Number: AP9
• Device Lot Number: C02159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 10/25/2017
• Supplement Dates Manufacturer Received: 09/27/2017
• Supplement Dates FDA Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1