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

Model Number	5MAXACE132KIT-A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
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 benchmark bmx96 access system (benchmark max), a penumbra system ace 60 reperfusion catheter (ace60), a velocity delivery microcatheter (velocity), a penumbra system 4max reperfusion catheter (4maxc) and a guidewire.It was noted that the patient anatomy was tortuous.During the procedure, the physician could not advance the benchmark max to the high cervical.Therefore, the benchmark max was placed in the common carotid.Next, while advancing the ace60 with the velocity using a guidewire to the target vessel, the mid-shaft of the ace60 kinked due to patient¿s tortuous anatomy.Consequently, the velocity kinked at mid-shaft.Therefore, the ace60 and velocity were removed.The physician then used the 4maxc in place of ace60 with the same velocity.However, the 4maxc kinked due to the kink in the velocity.Therefore, the 4maxc and velocity were removed.The procedure was completed using another aspiration catheter and another microcatheter.It was also reported that no visible kink was noticed on the 4maxc by the penumbra sales representative.There was no report of an adverse effect to the patient.

• 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: 12587001
• Report Number: 3005168196-2021-02212
• Device Sequence Number: 16966376
• Product Code: NRY
• UDI-Device Identifier: 00814548017433
• UDI-Public: 00814548017433
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 10/06/2021
• 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 Model Number: 5MAXACE132KIT-A
• Device Catalogue Number: 5MAXACE132KIT-A
• 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: 09/07/2021
• Initial Report FDA Received Date: 10/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 100
• Date Report Sent to FDA: 01/01/2005