MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER; NRY

Catalog Number	RED43160
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned red43 confirmed that the device was fractured.This damage typically occurs if the device is advanced against resistance during use.It was reported that resistance was encountered while advancing the red43 through the rhv.If the rhv used in the procedure is not fully opened during advancement of red43 through the rhv, resistance may be encountered.Forceful retraction against this resistance may have contributed to the red43 fracture.The distal fractured segment was not returned for evaluation.Further evaluation revealed that the device was ovalized throughout its length.This damage was incidental to the complaint and may have occurred during packaging for return to penumbra.Penumbra devices 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.
Event or Problem Description
The patient was undergoing thrombectomy procedure in right m2 segment of the middle cerebral artery (mca) using a penumbra system red 43 reperfusion catheter (red43), a penumbra system red 62 reperfusion catheter (red62), a neuron max 6f 088 long sheath (neuron max), a neuron select catheter 6f (6f select), a rotating hemostasis valve (rhv), and a guidewire.It was reported that the patient¿s anatomy was not extremely tortuous.During the procedure, the neuron max was placed within the right internal carotid artery (ica) using the 6f select and the guidewire.The 6f select was removed, and then the red43 and the red62 were advanced together as a system over the guidewire to the target location.The physician completed one pass while withdrawing the red43 and red62 extracting most of the clot.The red43 and the red62 were then removed for flushing.After flushing the red43 and red62, prior to re-advancing the red43 and the red62 through the rhv, the red43 was noted to be two to three inches out of red62 and into the rhv.While attempting to re-advance the red43 and the red62 through the rhv, the physician experienced resistance.It was reported that the physician was able to advance the red43 and the red62 through the rhv and into the neuron max after some time.The red43 and the red62 continued to advance through the neuron max; however, the red43 did not appear to be advancing or retracting within the neuron max under fluoroscopy.The physician decided to remove the red43, the red62, and the guidewire.It was reported that the physician used syringe aspiration on the side of the neuron max while removing the red43, red62, and the guidewire.Upon removal, the physician noticed that the red43 distal end was missing.The syringe then expelled the red43 distal end with the marker band intact along with the syringe contents.The procedure was completed at this point after achieving thrombolysis in cerebral infarction (tici) 3 was achieved.

• Brand Name: PENUMBRA SYSTEM RED 43 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: 19093706
• Report Number: 3005168196-2024-00125
• Device Sequence Number: 7737529
• Product Code: NRY
• UDI-Device Identifier: 00815948025745
• UDI-Public: 815948025745
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K222808
• 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): 04/11/2024
• 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: RED43160
• Device Lot Number: F00008861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• 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: 03/15/2024
• Initial Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2023
• 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 Age: 78 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005