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

Catalog Number	PST2
Medical Device Problem Codes	Hole In Material (1293); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/31/2016
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 revealed that the tubing suction connector was blocked.The tubing was connected to the aspiration pump and no vacuum was present.Further evaluation revealed that the suction connector to the tubing was blocked by the adhesive that was used to bond the connector to the tubing.The blocked suction connector likely prevented the vacuum pressure from being present during preparation.No further damage was observed on the tubing.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 physician noticed that the penumbra system max aspiration tubing (tubing) had a hole and therefore, suction was not possible.The damaged tubing was found prior to use and was not used for the procedure.The procedure was completed using a new aspiration 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: 5621688
• Report Number: 3005168196-2016-00576
• Device Sequence Number: 13530069
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2016

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: 11/30/2018
• Device Catalogue Number: PST2
• Device Lot Number: F66376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2016
• Initial Report FDA Received Date: 04/29/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1