MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 5MAX ACE 68 REPERFUSION CATHETER; NRY

Catalog Number	5MAXACE068
Medical Device Problem Codes	Fracture (1260); Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned ace68 confirmed a fracture on the distal end.If the device is advanced against resistance, damage such as a kink and subsequent fracture may occur.Evaluation also revealed that the distal tip was shaped.The distal tip shaping during the procedure and the reported patient¿s tortuous anatomy may have contributed to resistance during use.Further evaluation revealed kinks and ovalizations on the device.This damage was likely incidental to the reported complaint and the root cause could not be determined.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.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 internal carotid artery (ica) and the right m1 segment of the middle cerebral artery (mca) using a penumbra system ace 68 reperfusion catheter (ace68), a non-penumbra sheath, and a guidewire.It should be noted that the patient''s anatomy was tortuous.During the procedure, the physician steam shaped the distal end of the ace68.Next, while advancing the ace68 through the sheath, the physician experienced resistance and after partially advancing the ace68 out of the distal end of the sheath, the ace68 would not advance further.Therefore, the physician decided to remove the ace68.Upon removal, the physician noticed that the ace68 was fractured at the distal end and connected by a wire.Therefore, the ace68 was no longer used in the procedure.The procedure was completed using a new ace68 and the same sheath.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM 5MAX 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: 17144595
• Report Number: 3005168196-2023-00280
• Device Sequence Number: 5744465
• Product Code: NRY
• UDI-Device Identifier: 00814548016535
• UDI-Public: 814548016535
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K161640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/16/2023
• 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: 06/24/2024
• Device Catalogue Number: 5MAXACE068
• Device Lot Number: H11509
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2023
• 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: 05/26/2023
• Initial Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2021
• 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
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005