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	Foreign Body In Patient (2687)
Date of Event	04/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Evaluation of the returned penumbra system red 72 silver reperfusion catheter (red72 silver) confirmed that the catheter was fractured on its distal end.Evaluation also revealed stretching near the fractured location indicating the red72 silver was likely retracted against resistance.If the red72 silver is retracted against resistance, stretching and subsequent fracture may occur.Based on the reported event, the tortuous patient's anatomy may have contributed to resistance during the procedure.The distal fractured segment was reported to have been left in the patient and was not returned for evaluation.Further evaluation revealed ovalization and kinks on the catheter shaft.This damage was incidental to the reported complaint and may have occurred during packaging for return to penumbra.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 middle cerebral artery (mca) using a penumbra system red 72 silver reperfusion catheter (red72 silver) and a benchmark bmx96 access system (bmx96).It should be noted that the patient's anatomy was tortuous but not overly tortuous.During the procedure, the physician advanced the bmx96 over the red72 silver.Next, the physician turned on aspiration and retracted the red72 silver and noticed that the distal end of the red72 silver was not moving.Subsequently, the physician felt resistance and noticed under fluoroscopy that the distal end of the red72 silver was fractured.The physician made the decision to leave the fractured catheter in the left terminus section of the internal carotid artery (ica).It was reported that the catheter that was left in place did not worsen the patient's initial symptoms.The patient was intubated and kept in the intensive care unit (icu).The patient had a subsequent hemicraniectomy due to the initial large infarct.

• 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: 21993163
• Report Number: 3005168196-2025-00157
• Device Sequence Number: 17262685
• Product Code: NRY
• UDI-Device Identifier: 00815948029989
• UDI-Public: 00815948029989
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K242104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: RED72KIT
• Device Lot Number: C00017077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 72 YR
• Patient Sex: Female