MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 HI-FLOW KIT; NRY

Catalog Number	5MAXACE132KIT-A
Medical Device Problem Codes	Split (2537); Physical Resistance (2578)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was disposed of by the hospital and is no longer available for return.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.This report is associated with mfr report number: 3005168196-2017-01835.The hospital disposed of the device.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left middle cerebral artery (mca) using penumbra system ace 60 hi-flow kits (ace60s).During the procedure, the physician successfully completed one pass using a non-penumbra microcatheter and stent retriever.The physician then attempted to make a second pass using the microcatheter and stent retriever, however the physician felt resistance advancing just past the proximal hub of the ace60.Upon inspection of the ace60, a split near the proximal end of the catheter was found and therefore, the ace60 was removed.The physician then advanced a second ace60 and the same microcatheter, guide wire, and stent retriever into the mca, however at that moment the patient began moving vigorously on the table.The physician administered more anesthesia and proceeded with the case, however the ace60, the microcatheter, and the guide wire were now curled up in the distal internal carotid artery (ica) and were kinked; therefore, the devices were removed.The procedure was completed using a new ace60, a new microcatheter, a new guide wire, and the same stent retriever.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM ACE 68 HI-FLOW KIT
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 6963740
• Report Number: 3005168196-2017-01834
• Device Sequence Number: 19163664
• Product Code: NRY
• UDI-Device Identifier: 00814548017433
• UDI-Public: 00814548017433
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2017

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: Physician
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 5MAXACE132KIT-A
• Device Lot Number: F77420
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR