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

Catalog Number	RED72KIT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using a velocity delivery microcatheter (velocity), a penumbra system red 72 reperfusion catheter (red72), a neuron max 6f 088 long sheath (neuron max), a neuron select catheter 5f (5f select), and a guidewire.During the procedure, the physician advanced the red72 over the velocity and guidewire through the sheath to the target location.Next, the velocity was retracted and upon removal, the mid-shaft of the velocity was noticed to be fractured.The velocity was removed in its entirety and was not used for the remainder of the procedure.The physician then performed a cranial angiography and noticed the clot migrated from the m1 segment to the right m2 segment.After the angiography was performed, a new velocity along with the red72 and guidewire were advanced to the m2 segment.The velocity and guidewire were then removed and the red72 was used to aspirate to complete the first pass.A cervical angiography revealed dissection of the cervical segment of the ica.Next, a guidewire was advanced across the cervical dissection and into the vessel.The patient was then given aspirin and brilinta.After twenty minutes, a carotid wall stent was navigated to the cervical dissection and the stent was deployed.After deploying the stent, an angio seal percutaneous device was used to close the dissection.It was reported there was no hematoma or hemorrhage after closing the arteriotomy site.The clot migration from m1 segment to m2 segment and the cervical dissection of the ica are unrelated to any penumbra devices used in the procedure.On 04-apr-2023, it was reported that the cec chair adjudicated cervical dissection of the ica to be an adverse event with a possible relationship to the penumbra system, and a probable relationship to the index procedure.
Additional Manufacturer Narrative
Vessel dissection is included as possible complications in the instructions for use (ifu) for the penumbra system.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.The product was not returned for evaluation.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: 1.3005168196-2023-00136.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by the penumbra clinical team on (b)(6) 2023: 1.Section b.Box 5.Describe event or problem.Please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up #01 mfr report:3005168196-2023-00209.This report is associated with mfr report number: 1.3005168196-2023-00136.2.3005168196-2023-00289.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) using a velocity delivery microcatheter (velocity), a penumbra system red 72 reperfusion catheter (red72), a neuron max 6f 088 long sheath (neuron max), a neuron select catheter 5f (5f select), a non-penumbra sheath, a non-penumbra wall stent, and guidewires.During the procedure, the physician advanced the red72 over the velocity and guidewire through the sheath to the target location.Next, the velocity was retracted and upon removal, the mid-shaft of the velocity was noticed to be fractured.The velocity was removed in its entirety and was not used for the remainder of the procedure.The physician then performed a cranial angiography and noticed the clot migrated from the m1 segment to the right m2 segment.After the angiography was performed, a new velocity along with the red72 and guidewire were advanced to the m2 segment.The velocity and guidewire were then removed and the red72 was used to aspirate to complete the first pass.A cervical angiography revealed dissection of the cervical segment of the ica.Next, a guidewire was advanced across the cervical dissection and into the vessel.The patient was then given aspirin and brilinta.After twenty minutes, a carotid wall stent was navigated to the cervical dissection and the stent was deployed.After deploying the stent, an angio seal percutaneous device was used to close the dissection.It was reported there was no hematoma or hemorrhage after closing the arteriotomy site.The clot migration from m1 segment to m2 segment and the cervical dissection of the ica are unrelated to any penumbra devices used in the procedure.On (b)(6)2023, it was reported that the cec chair adjudicated cervical dissection of the ica to be an adverse event with a possible relationship to the penumbra system, and a probable relationship to the index procedure.On (b)(6)-2023, it was reported that the cec chair adjudicated cervical dissection of the ica to be an adverse event with a possible relationship to the penumbra system, the neuron max, and a probable relationship to the index procedure.

• Brand Name: PENUMBRA SYSTEM RED 72 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: 16839289
• Report Number: 3005168196-2023-00209
• Device Sequence Number: 6823895
• Product Code: NRY
• UDI-Device Identifier: 00815948023932
• UDI-Public: 815948023932
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K211654
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2023
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2024
• Device Catalogue Number: RED72KIT
• Device Lot Number: F110151
• Was Device Available for Evaluation?: No
• 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: 02/27/2023
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005