MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 64 HI-FLOW KIT; NRY

Catalog Number	5MAXACE064KIT
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	05/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: the ace64 was kinked approximately 59.0 cm from the hub.Bends were present along the length of the ace64.Conclusions: evaluation of the returned ace64 revealed a kinked device.This type of damage typically occurs due to improper handling during removal from packaging.If a device is forcefully retracted at extreme angles during removal from the packaging or otherwise mishandled during preparation, damage such as kinks may occur.No other devices associated with the complaint were returned for evaluation.Penumbra catheters are visually 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 technician noted that the penumbra system ace 64 reperfusion catheter (ace64) was kinked upon removal from the packaging of the penumbra system ace 64 hi-flow kit (kit).The damage to the ace64 was found prior to use and therefore, was not used in the procedure.The procedure was completed using a new ace64.

• Brand Name: PENUMBRA SYSTEM ACE 64 HI-FLOW KIT
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 7625670
• Report Number: 3005168196-2018-01220
• Device Sequence Number: 1317462
• Product Code: NRY
• UDI-Device Identifier: 00814548016467
• UDI-Public: 00814548016467
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/23/2018

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: Radiologic Technologist
• Device Expiration Date: 01/02/2021
• Device Catalogue Number: 5MAXACE064KIT
• Device Lot Number: F81263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1