MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER; NRY

Catalog Number	RED72KIT
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
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.After multiple attempts, the penumbra sales representative was unable to obtain enough device information to identify the lot number.The only device identifiers known are: d1 (brand name), d2a (common device name), and d2b (product code).Without the lot number for this device, unique device identifier (udi) cannot be determined.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the left m1 segment of the middle cerebral artery (mca) using a penumbra system red72 reperfusion catheter (red72), a non-penumbra stent retriever, a non-penumbra microcatheter, and a guidewire.It was noted that the patient¿s anatomy was very tortuous.During the procedure, the physician completed one pass using the red72.The physician then advanced the red72 to the target location and deployed the stent retriever through it.It was reported that the physician experienced resistance advancing and retracting the red72.After the stent retriever was deployed, an angiogram was performed and revealed that the distal end of the red72 fractured in the patient¿s common carotid artery.The physician used a snare device to retrieve the fractured segment of the red72.The procedure was completed using a penumbra system red62 reperfusion catheter (red62), a penumbra system red 43 reperfusion catheter (red43), and the same non-penumbra microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned red72 confirmed that the catheter was fractured.The evaluation revealed stretching near the fractured location.If the red72 is retracted against resistance, damage such as stretching and a subsequent fracture may occur.The reported tortuous anatomy may have contributed to the reported resistance during the procedure.The distal fractured segment of red72 was not returned for evaluation.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided; therefore, the manufacturing records could not be reviewed.Please note that the following sections are being updated based on additional information provided by a penumbra representative on 1/22/2025: section d.Box 4.Catalog number.Section d.Box 4.Unique identifier.

• Brand Name: PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer (Section G): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• Manufacturer Contact: veronica farris ; one penumbra place; alameda, CA 94502 ; 5107483200
• MDR Report Key: 21097396
• Report Number: 3005168196-2025-00005
• Device Sequence Number: 8856957
• Product Code: NRY
• UDI-Device Identifier: 00815948023932
• UDI-Public: 00815948023932
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K211654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: RED72KIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown