MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM PUMP MAX CANISTER KIT; NRY

Catalog Number	PAPS2
Medical Device Problem Codes	Occlusion Within Device (1423); Device Handling Problem (3265)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, an investigation cannot be performed.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system pump canister kit.During the procedure, while attempting to initiate aspiration for the first pass, the hospital staff accidentally did not remove a plastic film from the canister lid, which obstructed the aspiration tubing.Consequently, there was no blood flow into the canister.After the plastic film was removed, another attempt was made to aspirate the blood clot using the same penumbra system.Thereafter, the blood clot was completely removed and the patient's thrombolysis in cerebral infarction (tici) grade was a 3.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM PUMP MAX CANISTER KIT
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6392873
• Report Number: 3005168196-2017-00314
• Device Sequence Number: 13469561
• Product Code: NRY
• UDI-Device Identifier: 00814548012384
• UDI-Public: 00814548012384
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,s
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2017

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 Catalogue Number: PAPS2
• Device Lot Number: F71867
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2017
• Initial Report FDA Received Date: 03/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR