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	02/23/2024
Type of Reportable Event	Serious Injury
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.Hematoma is included as a possible complication in the instructions for use (ifu) for the benchmark bmx96 system.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This report is associated with mfr report number: 1.3005168196-2024-00087.2.3005168196-2024-00088 h3 other text : placeholder.
Event or Problem Description
The patient was undergoing a medical procedure in the left internal carotid artery (ica) using a bmx96 access system (bmx96), benchmark 6f 071 delivery catheters (benchmark), and guidewires.It was noted that the patient¿s anatomy was tortuous, and the guidewires were placed in the petrous portion of the ica.During the procedure, while advancing the bmx96 to the target location, the physician fractured the bmx96.The physician then visualized under fluoroscopy that the midshaft of the bmx96 was fractured; however, the bmx96 was still intact.Therefore, the bmx96 was removed from the patient.The physician then decided to use a benchmark.While advancing the benchmark into the patient, the physician encountered resistance, and the proximal end of the benchmark became unraveled.Therefore.The benchmark was removed.A second benchmark was advanced into the target location; however, the physician decided to reposition the benchmark.While retracting the benchmark, the physician experienced resistance, and the proximal end of the benchmark became unraveled.Therefore, the second benchmark was removed.It was reported sheaths were not being used and that may have contributed to the damage noted on the bmx96 and the benchmark catheters.The procedure was completed using a new benchmark.After completion of the procedure, the physician noticed a hematoma in the patient¿s femoral artery.Therefore, pressure was applied on the hematoma for approximately forty-five minutes.

• 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: 18909266
• Report Number: 3005168196-2024-00086
• Device Sequence Number: 12485956
• 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: K213390
• 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
• Report Date (Section B): 03/14/2024
• 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 Expiration Date: 05/18/2026
• Device Catalogue Number: BMX9690BER125
• Device Lot Number: H00002859
• 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: Not provided
• Initial Report FDA Received Date: 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 88 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005