MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM RED 62 REPERFUSION CATHETER; NRY

Catalog Number	THNDRRED62SKIT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Perforation of Vessels (2135)
Date of Event	12/08/2022
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 right m2 segment of the middle cerebral artery (mca) using a penumbra system red 62 reperfusion catheter (red62), a velocity delivery microcatheter (velocity) and a non-penumbra sheath.During the procedure, the patient suffered a vessel rupture after the completion of the first pass.Therefore, the vessel was tamponaded with a balloon; however, the extravasation continued.Therefore, a coil occlusion was performed and the event was considered resolved.The vessel rupture was reported to be a serious adverse event with a possible relationship to the penumbra system and a definite relationship to the index procedure.On 22-dec-2022, an update was received from the site indicating that the vessel rupture was unrelated to the penumbra system.On 04-apr-2023, additional information indicated that the clinical events committee (cec) adjudicated that the vessel rupture was definitely related to the penumbra system and the index procedure.
Additional Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra clinical team indicated that the device was disposed of and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.Perforation and intracranial hemorrhage are included as possible complications in the instructions for use (ifu) for the penumbra system.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• Brand Name: PENUMBRA SYSTEM RED 62 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: 16841288
• Report Number: 3005168196-2023-00211
• Device Sequence Number: 15175775
• Product Code: NRY
• UDI-Device Identifier: 00815948024359
• UDI-Public: 815948024359
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K203440
• 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: 05/25/2025
• Device Catalogue Number: THNDRRED62SKIT
• Device Lot Number: F00000997
• 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: 12/12/2022
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 04/30/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Age: 42 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005