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

Catalog Number	PST2
Medical Device Problem Codes	Misconnection (1399); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2016-01274.
Event or Problem Description
The patient was undergoing a thrombectomy procedure for a cerebral infarction in the right middle cerebral artery (mca) using a penumbra system aspiration pump max 110v (pump max) and the penumbra system max aspiration tubing (tubing).During the procedure, although the patient had slightly tortuous vessels, the physician was able to approach the right mca with a penumbra system ace reperfusion catheter (ace).The physician's assistant prepared for the procedure by connecting the clean side of the tubing to the hub of the ace and setting up the pump max and canister for aspiration.The pump max was then turned on and aspiration was initiated.However, after waiting about ninety seconds, the physician noticed a gradual back flow of blood into the pump max and then noticed that the assistant had inappropriately connected the backside end of the tubing by mistake.Therefore, the pump max was immediately turned off and the devices were reconnected appropriately.The physician then re-initiated aspiration and noticed that the aspiration pressure was normal.Additionally, there was no longer a back flow of blood into the pump max.Thereafter, the procedure was completed using the same penumbra devices without any further issues.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The hospital disposed of the device.

• 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: 5934636
• Report Number: 3005168196-2016-01275
• Device Sequence Number: 25458
• Product Code: NRY
• UDI-Device Identifier: 00814548012025
• UDI-Public: 00814548012025
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2016

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: 02/28/2019
• Device Catalogue Number: PST2
• Device Lot Number: F68087
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/08/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2016
• Supplement Report FDA Received Date: 11/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR