MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED72 REPERFUSION CATHETER; NRY

Catalog Number RED72KIT

Device Problem Break (1069)

Patient Problem Vascular Dissection (3160)

Event Date 05/04/2022

Event Type  Injury  

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max), a penumbra system red 72 reperfusion catheter (red72), a velocity delivery microcatheter (velocity), a non-penumbra stent retriever, a penumbra select catheter, a non-penumbra sheath, and two guidewires.It was reported that there was a small dissection in the internal carotid artery (ica) prior to the procedure.During the procedure, the physician obtained access in the femoral artery using the 8f sheath.Then, the physician advanced the neuron max into the left internal carotid artery (ica) using the select catheter and guidewire.Next, the physician advanced the red72 over the velocity, and guidewire through the neuron max to the clot in the target vessel.Next, the physician removed the guidewire and advanced the stent retriever device through the velocity and into the target vessel.After removing the velocity, the physician initiated aspiration and successfully completed one pass using the red72 and stent retriever device.Subsequently, the physician removed the red72 and stent retriever device.The physician then completed another pass using the same steps.After the second pass, while retracting the red72 and stent retriever device through the neuron max, the physician experienced resistance.Therefore, the physician decided to remove the neuron max as well.Upon removal of the devices, the physician noticed the red72 to be unraveled in two areas at the distal end and the neuron max to be ovalized at the distal end.Therefore, the neuron max was not used for the remainder of the procedure.The physician then inserted a new neuron max to take the final pictures.The size of the dissection in the ica was noted to be larger than the size at the beginning of the procedure.The procedure was completed after the final pictures were taken.The use of the red72 and neuron max may have contributed to the worsening of the pre-existing dissection in the ica.It should be noted that no action was taken to treat the dissection of the ica.

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 1.3005168196-2022-00241.

Manufacturer Narrative

Vessel perforation is included as a possible complication in the instructions for use for the penumbra system.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.This report is associated with mfr report number: 1.3005168196-2022-00241.

• Brand Name: PENUMBRA SYSTEM RED72 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: 14527249
• MDR Text Key: 294596135
• Report Number: 3005168196-2022-00242
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815948023932
• UDI-Public: 815948023932
• 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: 01/01/2005,11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RED72KIT
• Device Lot Number: F109223
• 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
• Date Manufacturer Received: 11/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2021
• 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): Other
• Patient Age: 47 YR
• Patient Sex: Male