MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER; NRY

Model Number	5MAXACE132KIT-A
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2020
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 using a penumbra system ace 60 reperfusion catheter (ace60).During the procedure, after completing the first pass, the ace60 was removed.While flushing the ace60 in preparation for the second pass, the technologist noticed a small hole in the ace60.Therefore, the ace60 was no longer used.The procedure was completed using another ace60.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated on this follow-up #01 mfr report:3005168196-2020-01990.Section b.Box 5.Describe event or problem.H3 other text: placeholder.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system ace 60 reperfusion catheter (ace60), a velocity delivery microcatheter (velocity), and a guidewire.During the procedure, after completing the first pass, the ace60 was removed.While flushing the ace60 in preparation for the second pass, the technologist noticed a small hole in the proximal part of the ace60.Therefore, the ace60 was no longer used.The procedure was completed using another ace60 and the same velocity.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 10839803
• Report Number: 3005168196-2020-01990
• Device Sequence Number: 11581899
• Product Code: NRY
• UDI-Device Identifier: 00814548017433
• UDI-Public: 00814548017433
• Combination Product (Y/N): Y
• 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,Followup
• Report Date (Section B): 10/16/2020
• 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: 09/12/2020
• Device Model Number: 5MAXACE132KIT-A
• Device Catalogue Number: 5MAXACE132KIT
• Device Lot Number: F79501
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Date Report Sent to FDA: 01/01/2005