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

Catalog Number RED72SDKIT

Device Problem Fracture (1260)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2023

Event Type  malfunction  

Manufacturer Narrative

Please note that this complaint was submitted to the fda by the user facility with the following reference number: (b)(4).This device is available for return.A follow-up mdr will be submitted upon completion of the device investigation.

Event Description

The patient was undergoing a thrombectomy procedure in the right m1 segment of the middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72) and a non-penumbra guide sheath.During the procedure, the physician completed one pass using the red72.Upon removal, the physician noticed that the red72 was fractured at the mid-shaft.The physician then attempted to retract the fractured segment of the red72 and the guide sheath together; however, the remaining portion of the red72 could not be pulled out.Next, the physician used a non-penumbra stent retriever through a non-penumbra microcatheter to remove the fractured segment but was unsuccessful.The procedure ended at this point.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device is no longer available for return.Therefore, 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.

Manufacturer Narrative

The following sections are being updated based on additional information included in the user facility report submitted to the fda:3901330000-2023-8056.1.Section b.Box 1.Adverse event and/or product problem 2.Section b.Box 1.Outcomes attributed to adverse event 3.Section b.Box 5.Describe event or problem.

Event Description

The patient was undergoing a thrombectomy procedure in the right m1 segment of the middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72) and a non-penumbra guide sheath.During the procedure, the physician completed one pass using the red72.Upon removal, the physician noticed that the red72 was fractured at the mid-shaft.The physician then attempted to retract the fractured segment of the red72 and the guide sheath together; however, the remaining portion of the red72 could not be pulled out.Next, the physician used a non-penumbra stent retriever through a non-penumbra microcatheter to remove the fractured segment but was unsuccessful.The patient will require dual antiplatelet therapy lifelong.The procedure ended at this point.

• 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: 17848840
• MDR Text Key: 324678490
• Report Number: 3005168196-2023-00445
• 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,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/01/2005,03/13/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: RED72SDKIT
• Device Lot Number: F00006387
• Was Device Available for Evaluation?: No
• 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: 09/05/2023
• Initial Date FDA Received: 09/29/2023
• Supplement Dates Manufacturer Received: 01/31/2024; 02/06/2024
• Supplement Dates FDA Received: 02/07/2024; 03/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR