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

Catalog Number RED72SDKIT

Device Problems Fracture (1260); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2024

Event Type  malfunction  

Manufacturer Narrative

The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) terminus using a penumbra system red72 reperfusion catheter (red72), a sendit delivery device (sendit), penumbra system red 62 reperfusion catheter (red62), a non-penumbra sheath, a non-penumbra stent retriever, and a guidewire.During the procedure, the physician advanced the red72 with sendit into the target location over a guidewire.The sendit was then removed, and the physician initiated aspiration using the red72.After a couple of minutes of aspirating, the physician pulled on the red72 and felt a tug.It was reported that the distal third of the red72 was fractured.Therefore, the sheath and red72 was removed together as a unit.The physician placed a new sheath and advanced a new red72 into the vessel.After making three more passes using the red72, the clot could not be removed.The physician then removed the red72 and switched to a red62 with a stent retriever; however, the physician was only able to remove a small amount of clot using the stent retriever.The red62 and stent retriever was removed and was not used for the remainder of the procedure.The procedure was completed using two new non-penumbra catheters with the same sheath to achieve thrombolysis in cerebral infarction (tici) 3.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned red72 confirmed that the catheter was fractured and revealed stretching near the fractured location.Based on the damage at the fractured location, the catheter may have become pinned prior to retraction.If the red72 is retracted against resistance, the device may stretch and subsequently fracture.Further evaluation revealed kinks along the catheter shaft.This damage was incidental to the reported complaint and likely occurred during packaging of the device for return to penumbra.There was no visible damage to the non-penumbra device.During evaluation, a demonstration red72 was advanced through the returned non-penumbra device without an issue.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.H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER
• Type of Device: 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: 18871238
• MDR Text Key: 337443484
• Report Number: 3005168196-2024-00079
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948025943
• UDI-Public: 815948025943
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,03/14/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: RED72SDKIT
• Device Lot Number: F00008316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1