MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED72 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	04/13/2023
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.Vessel spasm 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.
Event or Problem Description
On (b)(6) 2023, the patient underwent a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system red72 reperfusion catheter (red72), penumbra system red 43 reperfusion catheter (red43), and a non-penumbra coaxial catheter.During the procedure, the physician completed three passes in the target location.While attempting to make the fourth pass, the physician noticed the partial division in the middle cerebral artery (mca) is irregular and narrow at its origin.Subsequently, a vasospasm had occurred in the right internal carotid artery (ica).The physician infused 10mg of intra-arterial verapamil into the right ica over a two-minute period.The event was considered resolved the same day with the infusion of verapamil.The vasospasm was reported to be a serious adverse event with a probable relationship to the penumbra system red reperfusion catheter and index procedure.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by penumbra clinical team on 07 july 23: section b.Describe event or problem.Note: the vasospasm was previously adjudicated to be a serious adverse event with a possible relationship to the index procedure and a possible relationship to the red72.However, on 07-july-2023, an update was received indicating that the vasospasm is unrelated to the red72.Therefore, this event is not considered reportable against the red72.
Event or Problem Description
On (b)(6) 2023, the patient underwent a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system red72 reperfusion catheter (red72), penumbra system red 43 reperfusion catheter (red43), and a non-penumbra coaxial catheter.During the procedure, the physician completed three passes in the target location.While attempting to make the fourth pass, the physician noticed the partial division in the middle cerebral artery (mca) is irregular and narrow at its origin.Subsequently, a vasospasm had occurred in the right internal carotid artery (ica).The physician infused 10mg of intra-arterial verapamil into the right ica over a two-minute period.The event was considered resolved the same day with the infusion of verapamil.The vasospasm was reported to be a serious adverse event with a probable relationship to the penumbra system red72 reperfusion catheter (red72) and index procedure.On 07 july 23, an update was received indicating that the vasospasm is unrelated to the red72.

• Brand Name: PENUMBRA SYSTEM RED72 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: 16924430
• Report Number: 3005168196-2023-00225
• Device Sequence Number: 7033131
• 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,Followup
• Report Date (Section B): 08/04/2023
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 08/04/2023
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005