MAUDE Adverse Event Report: PENUMBRA, INC. ACE; CATHETER, THROMBUS RETRIEVER

Model Number	5MAXACE068-R
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	12/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Mechanical thrombectomy procedure was being performed.Physician advanced through the guide catheter a sofia 5 french aspiration catheter using the snake technique with the.035 angle glide guidewire.Physician advanced this through the proximal tortuosity of the ica (internal carotid artery) and through the supraclinoid segment to the area of the thrombus.Physician then performed aspiration.This was performed in the standard fashion and after adequate aspiration, physician began gently removing the aspiration catheter while aspirating on the guide catheter also.Follow-up angiography was performed.Continued thrombus in the distal m1 segment with no change versus baseline was observed.Given the potential for recalcitrant clot and what felt like firm clot via the aspiration catheter, physician attempted to use the penumbra red.072 aspiration catheter.This was advanced over a velocity microcatheter along with a synchro 2 standard micro wire using roadmap angiography.Physician was able to advance the system past the proximal tortuosity but given the proximal tortuosity and tortuosity of the supraclinoid ica, physician was unable to advance the.072 aspiration catheter past the ophthalmic segment.Therefore, this was removed.Physician then advanced a penumbra.068 aspiration catheter, again over the velocity microcatheter and the synchro 2 standard micro wire.Physician was able to advance the aspiration catheter to the interface of the thrombus in the distal m1 segment.Physician then performed aspiration thrombectomy using the penumbra aspiration device.Physician then began removing the aspiration catheter in the standard fashion.However, while withdrawing this, physician could appreciate what felt like the distal aspect/tip of the aspiration catheter shearing and remaining in place.The catheter was removed and, indeed, this is what had occurred.The removed portion of the catheter was collected and will undergo the standard device failure protocol.The manufacturer of the device was contacted as well.Manufacturer response for catheter, thrombus retriever, ace (per site reporter) physician discussed the event with the manufacturer.

• Brand Name: ACE
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 16111369
• Report Number: 16111369
• Device Sequence Number: 12502991
• Product Code: NRY
• UDI-Device Identifier: 00815948022843
• UDI-Public: (01)00815948022843(17)231229(10)H11043
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 12/30/2022
• Report Date (Section F): 12/30/2022

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
• Operator of Device: Health Professional
• Device Model Number: 5MAXACE068-R
• Device Lot Number: H11043
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Race: Black Or African American
• Date Report Sent to FDA: 12/30/2022