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

Catalog Number	5MAXACE064KIT
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2018
Type of Reportable Event	Serious Injury
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 discarded the device.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system ace 64 hi-flow kit (kit).During the procedure, the tip of the penumbra system ace 64 reperfusion catheter (ace64) broke off within the internal carotid artery of the patient after being advanced through a neuron max 6f 088 long sheath (neuron max).The physician, therefore, used a retrieval device to remove the tip of the ace64.The procedure was then completed using the same neuron max and a new catheter.There was no report of an adverse effect to the patient.

• 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: 7550883
• Report Number: 3005168196-2018-01074
• Device Sequence Number: 10833952
• Product Code: NRY
• UDI-Device Identifier: 00814548016467
• UDI-Public: 00814548016467
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/08/2020
• Device Catalogue Number: 5MAXACE064KIT
• Device Lot Number: C05832
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1