MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM MAX ASPIRATION TUBING; NRY

Catalog Number	PST2
Medical Device Problem Codes	Occlusion Within Device (1423); Out-Of-Box Failure (2311); Aspiration Issue (2883); Device Operational Issue (2914)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the suction connector to the penumbra system max aspiration tubing (tubing) was blocked.Conclusions: evaluation of the returned device confirmed that when the tubing was connected to a demonstration aspiration pump, no vacuum was present.Further evaluation revealed that the suction connector to the tubing was blocked by an adhesive.The blocked suction connector likely prevented the vacuum pressure from being present during preparation.Penumbra devices are 100% visually evaluated 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 thrombectomy procedure, the hospital staff noticed that the penumbra system max aspiration tubing (tubing) was occluded and did not aspirate.The defective tubing was found prior to use and was not used for the procedure.The procedure was completed using a new tubing.

• Brand Name: PENUMBRA SYSTEM MAX ASPIRATION TUBING
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5417563
• Report Number: 3005168196-2016-00149
• Device Sequence Number: 19132529
• Product Code: NRY
• UDI-Device Identifier: 00814548012025
• UDI-Public: 00814548012025
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Report Date (Section B): 01/12/2016

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: Health Professional
• Device Expiration Date: 07/31/2018
• Device Catalogue Number: PST2
• Device Lot Number: F64892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2016
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/08/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1