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

Catalog Number	RED72SDKIT
Medical Device Problem Codes	Fracture (1260); Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.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: 1.3005168196-2024-00363 2.3005168196-2024-00365.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) and the m1 segment of the middle cerebral artery (mca) using a penumbra system red 43 reperfusion catheter (red43), a penumbra system red 72 reperfusion catheter (red72), a benchmark bmx96 access system (bmx96), and a non-penumbra sheath (8f).During the procedure, the right femoral artery was accessed with the sheath.The physician advanced a bmx96 and red72 to the target location.It was reported that the red72 was unable to be advanced past the cavernous segment of the ica.The physician then advanced a red43 through the red72 to the target location.After initiating aspiration, the distal portion of the red43 was noticed to be fractured under fluoroscopy.The fractured segment of the red43 was noticed to be against the thrombus in the m1.The physician removed the proximal segment of the red43.Next, while removing the red72 from the bmx96, the physician noted resistance.The physician then decided to remove the red72 and bmx96 together from the patient, however, resistance was encountered and, subsequently, the red72 and bmx96 stretched and fractured at the distal location within the sheath.After removal of the proximal segments of the red72 and bmx96, the distal segments of the catheters were noticed to be stuck within the sheath.It was reported that the sheath became kinked while attempting to remove the proximal segments of the red72 and bmx96.The sheath containing the fractured segments of red72 and bmx96 was removed.To remove the fractured segment of the red43, the physician advanced a neuron max 6f 088 long sheath (neuron max), a non-penumbra catheter, and a stent retriever through left femoral access, however, the fractured segment could not be removed.The procedure ended at this point.No additional information was provided.

• Brand Name: PENUMBRA SYSTEM RED 72 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: 20582885
• Report Number: 3005168196-2024-00364
• Device Sequence Number: 8555638
• Product Code: NRY
• UDI-Device Identifier: 00815948025943
• UDI-Public: 00815948025943
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K211654
• 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
• Report Date (Section B): 10/31/2024
• 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: RED72SDKIT
• Device Lot Number: F00012609
• Was Device Available for Evaluation?: No
• 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: 10/07/2024
• Initial Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2024
• 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
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005