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

Catalog Number	5MAXACE132KIT
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system ace 60 hi-flow kit.During the procedure, the physician felt resistance while advancing the penumbra system ace 60 reperfusion catheter (ace60), through the cross cut valve of a non-penumbra sheath and, consequently, the tip of the ace60 became ovalized.Therefore, the ace60 was removed and the procedure was completed using a new catheter and the same sheath.There was no report of an adverse effect to the patient.

• 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: 8203079
• Report Number: 3005168196-2018-02524
• Device Sequence Number: 1671016
• Product Code: NRY
• UDI-Device Identifier: 00814548017433
• UDI-Public: 00814548017433
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 11/29/2018
• Report Date (Section F): 01/01/2005

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: 08/15/2026
• Device Catalogue Number: 5MAXACE132KIT
• Device Lot Number: F85340
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005