MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 60 HI-FLOW KIT; NRY

Catalog Number	5MAXACE132KIT
Medical Device Problem Codes	Kinked (1339); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Results: the penumbra system ace 60 reperfusion catheter(ace 60) was kinked approximately 46.0 and 58.0 cm from the hub.Conclusions: evaluation of the returned device confirmed that it was kinked.This type of damage typically occurs due to improper handling during removal from the packaging.If the hub of the ace 60 is manipulated or withdrawn from the packaging shell prior to removing the tubing tray, damage such as this may occur.Penumbra catheters are inspected during in-process inspection and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 lab staff noticed a kink in the mid-shaft of the penumbra system ace 60 reperfusion catheter (ace 60) upon opening the penumbra system ace 60 hi-flow kit (kit) and removing the tubing cover from the ace 60 packaging.Subsequently, the ace 60 was removed from the packaging and the physician then attempted to fix the kink but further damaged the ace 60 instead.The kinked ace 60 was found prior to use and therefore, was not used in the procedure.The procedure was completed using a new kit.

• Brand Name: PENUMBRA SYSTEM ACE 60 HI-FLOW KIT
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6224092
• Report Number: 3005168196-2017-00001
• Device Sequence Number: 675145
• Product Code: NRY
• UDI-Device Identifier: 00814548017433
• UDI-Public: 00814548017433
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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): 12/05/2016

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: Other
• Device Expiration Date: 05/06/2019
• Device Catalogue Number: 5MAXACE132KIT
• Device Lot Number: F69227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2016
• Initial Report FDA Received Date: 01/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1