MAUDE Adverse Event Report: PENUMBRA, INC. BENCHMARK BMX 81 ACCESS SYSTEM; DQY, QJP

Catalog Number	BMX7F105M
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a benchmark bmx 81 access system (bmx81) and a non-penumbra microcatheter.It was reported that the patient¿s anatomy was tortuous.During the procedure, while advancing the bmx81 through the radial artery, the physician experienced resistance after encountering a radial loop of the artery.Next, upon removal, the physician noticed that the bmx81 was kinked and fractured at the distal location.The procedure was completed using a benchmark bmx96 access system (bmx96) and the same microcatheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Correction: please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up #01 mfr report:3005168196-2023-00216 1.Section h.Box 6.Device code 3.Evaluation of the returned benchmark max 81 confirmed a fracture on its distal shaft.Evaluation revealed that the device was kinked at the fractured location.This indicates that the bmx81 was kinked prior to fracture.If the bmx81 is advanced against resistance during the procedure, damage such as a kink and subsequent fracture may occur.The reported patient¿s tortuous anatomy likely contributed to the resistance during the procedure.Further evaluation of the device revealed a kink on the proximal shaft.Based on the damaged location this damage was likely incidental to the complaint.Penumbra products are visually 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.

• Brand Name: BENCHMARK BMX 81 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: 16887498
• Report Number: 3005168196-2023-00216
• Device Sequence Number: 6174264
• Product Code: DQY
• UDI-Device Identifier: 00815948024618
• UDI-Public: 815948024618
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K221822
• 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): 05/25/2023
• 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: 01/22/2026
• Device Catalogue Number: BMX7F105M
• Device Lot Number: F00005093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2023
• 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: 04/13/2023
• Supplement Date Received by Manufacturer: 05/05/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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