MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER; NRY

Catalog Number	3MAXC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	11/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery (ica) and the m1 segment of the middle cerebral artery (mca) using a penumbra system 3max reperfusion catheter (3maxc), a red 68 reperfusion catheter (red68), a non-penumbra balloon guide catheter, a penumbra engine (engine), and a guidewire.During the procedure, the physician successfully completed one pass and aspirated the thrombus using the balloon guide catheter.After flushing the 3maxc, red68, and the balloon guide catheter, the physician advanced the 3maxc and red68 over the guidewire for a second pass to open the occluded m1 branch.After reaching the surface of the clot, the physician attempted to retract the 3maxc and guidewire to start aspiration.However, the physician experienced resistance and could not retract the 3maxc and guidewire.The physician then tightened his grip and, felt the 3maxc and guidewire become loose, and retracted the 3maxc and guidewire through the balloon guide catheter.Upon removal of the 3maxc, the physician performed an angiogram and noticed that the distal length of the 3maxc fractured and was pushed back into the ica and the anterior cerebral artery (aca) when the physician attempted to retrieve the 3maxc.Another diagnostic run was performed, and the physician noticed that the m1 segment of the mca was open.The physician then decided to snare the 3maxc fragment.The physician was able to retrieve the 3maxc fragment after several attempts.It was reported that during the 3maxc retrieval, thrombus formation was noted in the ica.It was reported that after retrieving the fractured 3maxc, the physician noticed on the angiogram that there were multiple occlusions in the distal part of the aca and m2 segment.The intima layer of the ica showed signs of damage due to the multiple passes made with the snare; therefore, the physician did not perform additional passes to aspirate the clots.The patient was administered extra heparin, and it was noted that the physician had difficulty closing the groin puncture because of the extra anticoagulation.The procedure ended at this point.
Additional Manufacturer Narrative
Thrombus is included as a possible complication in the instructions for use (ifu) for the penumbra system.Evaluation of the returned 3maxc confirmed a fracture on the distal shaft.Further evaluation revealed that the catheter shaft was stretched, and the non-penumbra guidewire was stuck.If the 3maxc is retracted against resistance, damage such as stretching, and a subsequent fracture may occur.Based on the reported complaint, the root cause of resistance during the procedure could not be determined.Further evaluation revealed kinks along the catheter shaft.This damage was incidental to the complaint and likely occurred during packaging for return to penumbra.Penumbra catheters 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.

• Brand Name: PENUMBRA SYSTEM 3MAX 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: 18312787
• Report Number: 3005168196-2023-00549
• Device Sequence Number: 15133055
• Product Code: NRY
• UDI-Device Identifier: 00814548019956
• UDI-Public: 814548019956
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K160449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2024
• 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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/14/2026
• Device Catalogue Number: 3MAXC
• Device Lot Number: F00006691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/17/2023
• Supplement Date Received by Manufacturer: 01/12/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 02/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2023
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005