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

Catalog Number	AP7
Medical Device Problem Codes	Detachment Of Device Component (1104); Material Rupture (1546); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Results: the sonic wire on the apollo wand (wand) was protruding out the distal tip of the wand.The sonic wire was fractured at the connection to the sonic connector in the abs knob on the proximal end of the wand.Conclusion: evaluation of the returned device revealed that a loud sound was heard and the sonic wire was protruding out the distal tip of the wand during the functional analysis.The wand was connected to the generator and powered on.The wand irrigated and aspirated without an issue.However, while depressing the foot pedal a loud sound was observed and the sonic wire began to protrude out the distal tip of the wand.Further evaluation of the returned device revealed that the sonic wire was fractured at the connection to the sonic connector in the abs knob.Extended use of the wand could cause heat to build up at the sonic connector, which may contribute to the sonic wire fatigue.The root cause of the loud noise that was heard during the procedure could not be determined.Penumbra devices 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 or Problem Description
The patient was undergoing a microneurosurgery procedure to treat an intra-cerebral hemorrhage (ich) using an apollo wand (wand).During the procedure, after a few minutes of use, a loud noise was heard.The penumbra sales representative inspected the wand¿s connection to the apollo generator (generator), and found that the black connector had become loose due to the vibration of the machine.The sales representative tightened the black connector, and felt that it had become very hot.The black connector was unable to stay tight; therefore, the sales representative held the black connector in place as the procedure continued.The noise continued and there was still a considerable amount of heat at the black connector, and so at this point the physician removed the wand from the patient and found that the vibration wire was protruding and was exposed outside of the tip of the wand.The wand was therefore not reused, and the procedure was completed using a new wand and the same generator.There was no report of an adverse effect to the patient.

• Brand Name: APOLLO WAND
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6807338
• Report Number: 3005168196-2017-01402
• Device Sequence Number: 2064378
• Product Code: GWG
• UDI-Device Identifier: 00814548016351
• UDI-Public: 00814548016351
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/25/2017

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
• Operator of Device: Physician
• Device Expiration Date: 02/23/2018
• Device Catalogue Number: AP7
• Device Lot Number: F74564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 08/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR