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

Model Number	BMX9680BER105-A
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note that this complaint was submitted to the fda by the user facility with the following reference number: 3900490000-2021-8010.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 medical procedure using a benchmark bmx96 access system (benchmark max), a neuron select catheter 6f (6f select) and a guidewire.During the procedure, while tracking a benchmark max over the 6f select in an arch to the target vessel, the physician noticed under fluoroscopy that the benchmark max appeared kinked and the benchmark max would not advance.Therefore, the benchmark max and the 6f select were removed.The procedure was completed using a non-penumbra sheath.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a medical procedure using a benchmark bmx96 access system (benchmark max), a neuron select catheter 6f (6f select) and a guidewire.During the procedure, while tracking a benchmark max over the 6f select in an arch to the target vessel, the physician noticed under fluoroscopy that the benchmark max appeared kinked and the benchmark max would not advance.Therefore, the benchmark max and the 6f select were removed.The procedure was completed using a non-penumbra sheath.There was no report of an adverse effect to the patient.The exact event date is unknown.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 07/19/2021: 1.Section b.Box 5.Describe event or problem.Evaluation of the returned benchmark max revealed an ovalization on the distal shaft.This damage was likely the reported kink.If the device is pinched or gripped during use, damage such as this may occur.This damage may have contributed to the resistance during advancement.Further evaluation revealed a kink on the mid-shaft.This damage was likely incidental to the reported complaint and may have occurred during packaging for return to penumbra.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
• MDR Report Key: 12139768
• Report Number: 3005168196-2021-01501
• Device Sequence Number: 19866293
• Product Code: DQY
• UDI-Device Identifier: 00815948022638
• UDI-Public: 00815948022638
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K201271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2021
• 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: 12/07/2023
• Device Model Number: BMX9680BER105-A
• Device Catalogue Number: BMX9680BER105
• Device Lot Number: F102555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 07/28/2021
• Initial Report FDA Received Date: 07/08/2021
• Supplement Report FDA Received Date: 07/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Date Report Sent to FDA: 01/01/2005