MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE068
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/27/2022
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 right m1 segment of the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68), a velocity delivery microcatheter (velocity), a penumbra system red 72 reperfusion catheter (red72), a penumbra engine (engine), a non-penumbra sheath, and a guidewire.During the procedure, the physician advanced the red72 over the velocity.It was reported that the patient¿s anatomy was tortuous.Therefore, the physician could only advance the red72 past the proximal tortuosity and tortuosity of the supraclinoid ica.However, the physician could not advance the red72 past the ophthalmic segment.Therefore, the red72 was removed from the patient.Next, the physician advanced the ace68 over the velocity to the target location and completed aspiration.Upon removal, it was noted the ace68 was broken at the distal part.Subsequently, the physician attempted to remove the distal part of the ace68 from the patient; however, it was unsuccessful.Therefore, the distal portion of the ace68 was left in the patient's vessel.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up #01 mfr report:3005168196-2023-00042 1.Section g.Box 3.Report source 2.Section h.Box 10./11.Additional narrative please note that this complaint was submitted to the fda by the user facility with the following reference number:(b)(4).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.H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM ACE 68 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 16219563
• Report Number: 3005168196-2023-00042
• Device Sequence Number: 5925603
• Product Code: NRY
• UDI-Device Identifier: 00815948022843
• UDI-Public: 815948022843
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K161640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2023
• 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: 12/29/2023
• Device Catalogue Number: 5MAXACE068
• Device Lot Number: H11043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 12/27/2022
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Date Report Sent to FDA: 01/01/2005