MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX HI-FLOW KIT; NRY

Catalog Number	3MAXCKIT
Medical Device Problem Codes	Fracture (1260); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the returned product display box was damaged.The penumbra system 3max reperfusion catheter (3max) was kinked approximately 5.0, 41.0, and 80.0 cm from the hub.The 3max was fractured approximately 57.0 cm from the hub.Conclusions: evaluation of the returned device revealed that the 3max was fractured near the middle of its length.This is likely due to mishandling during removal from packaging.If the 3max is forcefully withdrawn from the packaging shell before the tubing tray is removed, damage such as this may occur.Further evaluation revealed the 3max was kinked in multiple locations.This damage is likely incidental and may have occurred during packaging for return to penumbra.Further evaluation revealed that the package we received was damaged.This damage likely occurred during shipment back to penumbra.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.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 3max reperfusion catheter (3max) was fractured along its side upon removal from its packaging.The fractured 3max was found prior to use and therefore, was not used in the procedure.The procedure was completed using a new 3max.

• Brand Name: PENUMBRA SYSTEM 3MAX HI-FLOW KIT
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6244398
• Report Number: 3005168196-2017-00033
• Device Sequence Number: 10969689
• Product Code: NRY
• UDI-Device Identifier: 00814548016757
• UDI-Public: 00814548016757
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K160449
• 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): 12/13/2016

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: 01/05/2019
• Device Catalogue Number: 3MAXCKIT
• Device Lot Number: F67202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2016
• Initial Report FDA Received Date: 01/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1