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

Catalog Number	RED72SDKIT
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional device code that also apply to this complaint: 1601 (stretched).Evaluation of the returned red72 revealed stretching and ovalization on the distal shaft.This may be the reported kink on the distal location.If the device is manipulated against resistance, damage such as stretching and ovalizations may occur.It was reported that the patient¿s anatomy was very tortuous with acute turns.This may have contributed to resistance during the procedure.While flushing the red72 during decontamination, the most stretched distal region worsened; therefore, the device could not be functionally tested.Further evaluation revealed kinks on the proximal shaft.This damage was likely incidental to the complaint and may have 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.This report is associated with mfr report number: 1.3005168196-2024-00341.
Event or Problem Description
On (b)(6) 2024, the patient underwent a thrombectomy procedure in the m2 segment of the middle cerebral artery (mca) using a penumbra system red 72 reperfusion catheter (red72).It was reported that the patient¿s anatomy was very tortuous with acute turns.During the procedure, the physician noted that the red72 was difficult to advance and it required several attempts to track the red72 to the target location.After completing one pass, the physician decided to remove the red72.It was noted that the physician felt resistance while removing the red72.After removal, the red72 appeared to be kinked and stretched at the distal location.The procedure was completed with a penumbra system red 43 reperfusion catheter (red43).On (b)(6) 2024, the patient experienced a generalized tonic-clonic seizure event lasting one minute.The seizure was treated with medication (ativan).It was reported that the seizure occurred due to re-occlusion.A ct scan found re-occlusion in the mca/m2 arteries.The patient was put on single antiplatelet medication and discharged on (b)(6) 2024.The patient exited the study on (b)(6) 2024 and the event was considered unresolved at the time of study exit.On (b)(6) 2024, cec chair adjudicated reocclusion as a serious adverse event, possibly related to the index procedure and possibly related to penumbra system.

• 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: 20433706
• Report Number: 3005168196-2024-00340
• Device Sequence Number: 7627018
• Product Code: NRY
• UDI-Device Identifier: 00815948025943
• UDI-Public: 00815948025943
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/11/2024
• 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 Catalogue Number: RED72SDKIT
• Device Lot Number: F00011020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2024
• 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: 06/11/2024
• Initial Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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: 70 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005