MAUDE Adverse Event Report: PENUMBRA, INC. BENCHMARK BMX 96 ACCESS SYSTEM; DQY, QJP

Model Number	BMX9690SIM125-A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Vascular Dissection (3160); Ischemia Stroke (4418)
Date of Event	01/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ischemia, neurological deficits including stroke and vascular dissection are included as possible complications in the instructions for use (ifu) for the benchmark bmx96 system.The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.
Event or Problem Description
The patient underwent a thrombectomy procedure in the left internal carotid artery (ica) using a benchmark bmx96 access system (benchmark max) and a velocity delivery microcatheter (velocity).Upon completion of the procedure, the benchmark max was removed from the patient and the physician reported that the vessel appeared to be damaged.The patient was moved to the intensive care unit (icu) to recover.Later the same day, the patient suffered stroke-like symptoms and subsequently, a head computed tomography (ct) scan showed a complete infarct of the left hemisphere caused by a dissection of the cervical section of the ica.The patient was taken to the operating room (or) for an emergent hemi-crani procedure.
Event or Problem Description
The patient underwent a thrombectomy procedure in the left internal carotid artery (ica) using a benchmark bmx96 access system (bmx96) and a velocity delivery microcatheter (velocity).Upon completion of the procedure, the bmx96 was removed from the patient and the physician reported that the vessel appeared to be damaged.The patient was moved to the intensive care unit (icu) to recover.Later the same day, the patient suffered stroke-like symptoms and subsequently, a head computed tomography (ct) scan showed a complete infarct of the left hemisphere caused by a dissection of the cervical section of the ica.The patient was taken to the operating room (or) for an emergent hemi-crani procedure.

• Brand Name: BENCHMARK BMX 96 ACCESS SYSTEM
• Common Device Name: DQY, QJP
• 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: 15933963
• Report Number: 3005168196-2022-00553
• Device Sequence Number: 14552118
• Product Code: DQY
• UDI-Device Identifier: 00815948022652
• UDI-Public: 00815948022652
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023
• 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: 10/26/2023
• Device Model Number: BMX9690SIM125-A
• Device Catalogue Number: BMX9690SIM125
• Device Lot Number: F101483
• 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: 01/16/2021
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 01/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2020
• 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: 41 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005