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

Catalog Number	RED68
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 1.3005168196-2024-00239.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left internal carotid artery (ica) terminus using a penumbra system red 68 reperfusion catheter (red68), a penumbra system 3max reperfusion catheter (3maxc), a non-penumbra sheath, a stent retriever, and a guidewire.It was noted that the patient's anatomy was tortuous.During the procedure, the physician completed passes in the target location using the red68 and 3maxc.The physician then re-advanced the red68 and 3maxc to the clot and attempted to advance the stent retriever through the red68.It was reported that resistance was encountered when placing the red68 and stent retriever due to the patient¿s anatomy, causing the physician to use additional force.After several attempts to advance the stent retriever, the physician decided to remove it with the red68 and 3maxc and again experienced resistance.Upon removal, it was noted that both the red68 and the 3maxc fractured into two pieces approximately five centimeters from the proximal end.Therefore, the red68 and the 3maxc were not used for the remainder of the procedure.The procedure was completed using a non-penumbra aspiration catheter and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned red68 confirmed a fracture on the proximal shaft.If the red68 is manipulated against resistance, damage such as a kink and subsequent fracture may occur.The reported patient¿s tortuous anatomy likely contributed to resistance during retraction.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.This report is associated with mfr report number: 1.3005168196-2024-00239.H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM RED 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: 19696754
• Report Number: 3005168196-2024-00238
• Device Sequence Number: 18144831
• Product Code: NRY
• UDI-Device Identifier: 00815948024090
• UDI-Public: 00815948024090
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K211411
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2024
• 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 Catalogue Number: RED68
• Device Lot Number: H00004031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2024
• 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: 06/11/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 07/08/2024
• Supplement Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2023
• 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 Sex: Female
• Date Report Sent to FDA: 01/01/2005