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

Catalog Number	BMX9690SIM125
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
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 right carotid artery using a benchmark bmx96 access system (bmx96), a non-penumbra catheter (simmons), and a guidewire.During the procedure, the physician placed an angioplasty and carotid stent.Next, while advancing a bmx96 and sheath to the target vessel, sheath and bmx96 fractured at the proximal location.Therefore, the sheath and bmx96 were removed together.The procedure was ended at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned bmx96 confirmed it was fractured.If a device is being advanced through the bmx96 at an angle or otherwise torqued against resistance during advancement, damage such as a kink may occur and if the kink is further manipulated, the kink may worsen to a fracture.Based on the reported event, the root cause of resistance could not be determined.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.
Additional Manufacturer Narrative
Please note that the following sections were incorrectly reported on the initial mfr report and are being corrected on this follow-up mfr report: section h.Box 3.Device returned to manufacturer?; section h.Box 6.Results code 1 ; section h.Box 6.Conclusions code 1; section h.Box 10./11.Additional narrative and/or corrected data.This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Please note that the following section was updated on this follow-up #3 mfr report: 1.Section b.Box 5.Describe event or problem.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right carotid artery using a benchmark bmx96 access system (bmx96), a non-penumbra catheter, and guidewire.During the procedure, the physician placed an angioplasty and carotid stent.Next, while advancing a bmx96 to the target vessel, the bmx96 fractured on the proximal end.Therefore, the bmx96 was removed.The procedure was ended at this point.There was no report of an adverse effect to the patient.

• 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: 19703384
• Report Number: 3005168196-2024-00243
• Device Sequence Number: 12692858
• Product Code: DQY
• UDI-Device Identifier: 00815948026308
• UDI-Public: 00815948026308
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup,Followup,Followup
• Report Date (Section B): 11/05/2024
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: BMX9690SIM125
• Device Lot Number: H00004568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 06/12/2024
• Supplement Date Received by Manufacturer: 01/14/2005; 08/09/2024; 01/14/2005
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 09/06/2024; 09/06/2024; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• 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 Age: 83 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005