MAUDE Adverse Event Report: PENUMBRA, INC. BENCHMARK BMX96 ACCESS SYSTEM; DQY, QJP

Catalog Number	BMX9690BER125
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	03/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a thrombectomy procedure to treat an m2 occlusion of the middle cerebral artery (mca) using a benchmark bmx96 access system (bmx96), penumbra system red 62 reperfusion catheter (red62), and a velocity delivery microcatheter (velocity).After approximately halfway into the procedure using the red62 and velocity, the physician noticed the proximal end of the bmx96 had fractured.The physician continued and successfully completed the procedure using the red62 and velocity.Afterwards, the physician removed the red62, velocity, and bmx96 and noticed a minor hematoma had occurred at the proximal femoral artery.The patient was then transferred to the intensive care unit (icu) to recover.
Additional Manufacturer Narrative
The device has been returned and the investigation results are pending.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.
Additional Manufacturer Narrative
Evaluation of the returned bmx96 revealed kinks on the proximal end and a hole was present at one of the kinked locations.This damage is likely the reported fracture.If the device is manipulated at extreme angles during use, damage such as kinks may occur.Further evaluation revealed damage at the distal tip.This damage is likely incidental to the reported complaint.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.H3 other text: placeholder.

• Brand Name: BENCHMARK BMX96 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: 16778808
• Report Number: 3005168196-2023-00181
• Device Sequence Number: 6849508
• Product Code: DQY
• UDI-Device Identifier: 00815948022645
• UDI-Public: 815948022645
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/27/2023
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/16/2025
• Device Catalogue Number: BMX9690BER125
• Device Lot Number: H00000506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2023
• 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: 03/27/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 04/20/2023
• Supplement Report FDA Received Date: 04/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2022
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005