MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE132KIT
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
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
During preparation for a medical procedure using a penumbra system ace 60 reperfusion catheter (ace60), the physician was attempting to advance a penumbra system aspiration 3max reperfusion catheter (3maxc) into the ace60 on the back table.During advancement, it was reported that the 3maxc was only able to advance approximately 15 cm out from the tip of the ace60 and would not advance further.The physician then decided to remove the ace60 and noted that something was within the inner diameter, preventing the 3maxc from advancing further.The issue with the ace60 was found prior to use and therefore it was not used in the procedure.The procedure was completed using a penumbra system ace 64 reperfusion catheter (ace64) and the same 3maxc.

• Brand Name: PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8656620
• Report Number: 3005168196-2019-01064
• Device Sequence Number: 14028305
• Product Code: NRY
• UDI-Device Identifier: 00814548017433
• UDI-Public: 00814548017433
• Combination Product (Y/N): Y
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/01/2019
• 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: 02/13/2022
• Device Catalogue Number: 5MAXACE132KIT
• Device Lot Number: F88553
• 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: 05/01/2019
• Initial Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Date Report Sent to FDA: 01/01/2005