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

Catalog Number	AP7
Medical Device Problem Codes	Complete Blockage (1094); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the apollo wand (wand) was slightly bent.Conclusions: evaluation of the returned device could not confirm the reported leak.The wand was connected to a demonstration apollo system and functionally tested.No leaks were observed during the functional test.Further evaluation revealed that the wand tip was slightly bent.The root cause of this damage could not be determined.All wands are visually inspected during in-process inspection.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report numbers: 3005168196-2016-01769.
Event or Problem Description
The patient was undergoing a microneurosurgery procedure treating an intracranial hemorrhage (ich) using apollo wands (wands).During the procedure, while using the wand, the physician noticed there was a leak at the hub of the wand and it became clogged and unusable.The wand was therefore removed and the procedure was continued using a new wand.The physician reported that although the new wand was leaking as well; it was successfully used to complete the procedure.There was no report of an adverse effect to the patient.

• Brand Name: APOLLO WAND, SHORT
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6143541
• Report Number: 3005168196-2016-01768
• Device Sequence Number: 19071335
• Product Code: GWG
• UDI-Device Identifier: 00814548013596
• UDI-Public: 00814548013596
• 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): 11/04/2016

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 Expiration Date: 02/07/2017
• Device Catalogue Number: AP7
• Device Lot Number: F67770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2016
• Initial Report FDA Received Date: 12/02/2016
• 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