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

Catalog Number	APTUBE1
Medical Device Problem Codes	Disconnection (1171); Out-Of-Box Failure (2311); Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the distal segment of the tubing (bpt tubing) was disconnected from the proximal segment of the tubing (pvc tubing).The two segments were able to be securely re-connected by a penumbra investigator.Conclusions: evaluation of the returned tubing revealed that the distal segment of the tubing (bpt tubing) was disconnected from the proximal segment of the tubing (pvc tubing).The two segments were able to be securely re-connected by the penumbra investigator.The root cause of this failure could not be determined.All these devices 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.
Event or Problem Description
During preparation for a microneurosurgery procedure, the technician noticed that the apollo irrigation tubing (tubing) was disconnected into two pieces upon removal from the packaging.The disconnected tubing was found prior to use and therefore, was not used for the procedure.The procedure was successfully completed using a new tubing.

• Brand Name: APOLLO IRRIGATION TUBING
• Common Device Name: GWG
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5696062
• Report Number: 3005168196-2016-00733
• Device Sequence Number: 179662
• Product Code: GWG
• UDI-Device Identifier: 00814548013602
• UDI-Public: 00814548013602
• 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): 05/04/2016

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: Other
• Device Expiration Date: 11/05/2018
• Device Catalogue Number: APTUBE1
• Device Lot Number: F66375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2016
• Initial Report FDA Received Date: 06/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1