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

Catalog Number	BMX9680BER105
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	01/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the basilar/vertebral artery using a benchmark bmx96 access system (bmx96), a velocity delivery microcatheter (velocity), a non-penumbra aspiration catheter and a guidewire.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician attempted to gain femoral access using the bmx96; however, femoral access was not possible.Therefore, the physician decided to use radial approach using the bmx96.It was reported that the radial artery of the patient was tight and would only accommodate the bmx96 up to the brachial artery segment.The physician then advanced the non-penumbra aspiration catheter over the guidewire and the velocity through the bmx96 to the vertebral artery; however, the aspiration catheter had reached the hub of the bmx96 at this point and would not advance further to the target vessel.  the physician could not treat the stroke due to a lack of length in the system, and therefore, the velocity, aspiration catheter and guidewire were removed.The physician then inserted a different guidewire to remove the bmx96.While attempting to remove the bmx96, the physician experienced resistance and broke the bmx96 near the mid-shaft.It was reported that the bmx96 was tight in the vessel.The patient was subsequently transferred to the operating room and part of the bmx96 in the brachial artery was surgically removed; however, part of the bmx96 in the radial artery could not be removed and the vessel became occluded.The procedure ended at this point.It was reported that the patient have a patent ulnar artery that is still supplying blood to the hand.
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #01 mfr report: 1.Section h.Box 6.Conclusions code 1 & 2 h3 other text : placeholder.

• 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: 16400994
• Report Number: 3005168196-2023-00080
• Device Sequence Number: 5605365
• Product Code: DQY
• UDI-Device Identifier: 00815948022638
• UDI-Public: 815948022638
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/04/2023
• 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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: BMX9680BER105
• 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: 01/23/2023
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 05/04/2023
• 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: Required Intervention
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005