MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER; NRY

Catalog Number	RED62SKIT
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.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 red 62 reperfusion catheter (red62), velocity delivery microcatheter (velocity), and a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician obtained access using the neuron max and then advanced the red62 and velocity to the face of the clot.Next, the physician attempted to remove the velocity out from the red62 to initiate aspiration; however, the velocity was stuck and could not be removed.The physician then attempted to remove the red62 and velocity together, but both devices were stuck.Consequently, the physician continued to pull on the red62 and broke it in half.It was reported that the only half of the broken red62 was removed along with the entire velocity.Therefore, the physician advanced the neuron max over the other broken half of the red62 and removed both the red62 and neuron max together as a unit.The procedure was completed using a new aspiration catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned red62 confirmed that the catheter was fractured and revealed stretching proximal to the fractured location.If the red62 is retracted against resistance, damage such as stretching and subsequent fracture may occur.The observed kink on the neuron max likely contributed to the resistance while retracting the red62 from the neuron max.The fractured distal segment was not returned for evaluation.Further evaluation of the device revealed an additional fracture on the proximal end.This damage was likely incidental to the complaint.The fractured proximal segment with the hub was not returned for evaluation.Penumbra products are visually 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.

• Brand Name: PENUMBRA SYSTEM RED 62 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: 16828494
• Report Number: 3005168196-2023-00203
• Device Sequence Number: 1906979
• Product Code: NRY
• UDI-Device Identifier: 00815948023536
• UDI-Public: 815948023536
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2023
• 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: 09/14/2025
• Device Catalogue Number: RED62SKIT
• Device Lot Number: F00003050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/05/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2022
• 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: 42 YR
• Patient Sex: Female
• Patient Weight: 115 KG
• Date Report Sent to FDA: 01/01/2005