MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER; NRY

Catalog Number RED62SKIT

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

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

Event Date 03/28/2023

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.This report is associated with mfr report number: 3005168196-2023-00183.

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system red 62 reperfusion catheter (red62), a velocity delivery microcatheter (velocity) and a non-penumbra guide catheter.It should be noted that the patient''s anatomy was extremely tortuous.During the procedure, while attempting to advance the red62 and the velocity through the guide catheter to the target vessel, the physician experienced resistance.Therefore, the red62 and the velocity were removed.Upon removal, the physician noticed the red62 and the velocity to be fractured.It was reported that the guide catheter became ovalized due to tortuosity of the patient''s vessels.The procedure ended at this point.The patient could not be treated due to extremely tortuous anatomy.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report:3005168196-2023-00182.

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system red 62 reperfusion catheter (red62), a velocity delivery microcatheter (velocity) and a non-penumbra guide catheter.It should be noted that the patient''s anatomy was extremely tortuous.During the procedure, while attempting to advance the red62 and the velocity through the guide catheter to the target vessel, the physician experienced resistance.Therefore, the red62 and the velocity were removed.Upon removal, the physician noticed the red62 and the velocity to be kinked.It was reported that the guide catheter became ovalized due to tortuosity of the patient''s vessels.The procedure ended at this point.The patient could not be treated due to extremely tortuous anatomy.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned red62 could not confirm the reported fractures.Evaluation revealed multiple kinks along the distal shaft.If the device is manipulated against resistance, damage such as this may occur.The reported tortuosity of the patient¿s anatomy may have contributed to resistance during the procedure.During evaluation, the red62 along with the returned velocity and non-penumbra guidewire were advanced through a demonstration neuron max with resistance due to the damage on the distal end.Penumbra devices 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.Note: based on the investigation findings, this is not considered a reportable event.This event did not and, if it were to recur, it would not cause or contribute to serious deterioration or death.This report is associated with mfr report number: 3005168196-2023-00183.H3 other text: placeholder.

• Brand Name: PENUMBRA SYSTEM RED 62 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: 16779178
• MDR Text Key: 313693200
• Report Number: 3005168196-2023-00182
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948023536
• UDI-Public: 815948023536
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203440
• 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,Followup
• Report Date: 01/01/2005,05/16/2023

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: RED62SKIT
• Device Lot Number: F00002901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• 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: 03/29/2023
• Initial Date FDA Received: 04/20/2023
• Supplement Dates Manufacturer Received: 01/14/2005; 01/14/2005
• Supplement Dates FDA Received: 05/16/2023; 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2022
• 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