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

Catalog Number	THNDRRED72KIT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vasoconstriction (2126)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Vasospasm is included as a possible complication in the instructions for use (ifu) for the penumbra system.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: 1.3005168196-2023-00457.H3 other text : placeholder.
Event or Problem Description
The patient underwent a thrombectomy procedure in the left middle cerebral artery (mca) and internal carotid artery (ica) using a penumbra system red72 reperfusion catheter (red72), a penumbra system red 62 reperfusion catheter (red62), and a neuron max 6f 088 long sheath (neuron max).During the procedure, the red72 was advanced to the anterior m2 branch of the mca.Aspiration was performed using the red72 under direct fluoroscopy.A follow-up angiography revealed recanalization of the m2; however, extensive nonocclusive thrombus was noted throughout the petrous and cavernous ica segments.The red72 was then navigated to the proximal petrous ica segment to perform additional aspiration.A follow-up angiography demonstrated complete recanalization of the petrous cavernous ica segments.Moderate vasospasm was noted in the cervical ica, the proximal m1 and the anterior m2.To treat the vasospasm, 10mg of verapamil was administered.Further angiographic evaluation demonstrated nonocclusive thrombus in the m2.Next, the neuron max was placed in the proximal left ica and the red62 was advanced to the anterior m2, and continuous aspiration was performed under fluoroscopy.A follow-angiography demonstrated complete patency of the m2.Moderate to severe vasospasm was noted in the m2.Additional dosage of 10mg of verapamil was administered.The procedure was completed with further aspiration using the red62.The vasospasm was considered resolved the same day.The vasospasm was reported to be a serious adverse event with a possible relationship to the penumbra system reperfusion catheters and a probable relationship with 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: 17924424
• Report Number: 3005168196-2023-00456
• Device Sequence Number: 14195923
• Product Code: NRY
• UDI-Device Identifier: 00815948024380
• UDI-Public: 815948024380
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 10/12/2023
• 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: 06/29/2025
• Device Catalogue Number: THNDRRED72KIT
• Device Lot Number: F00001781
• 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: 09/13/2023
• Initial Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2022
• 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: 34 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005