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

Model Number	BMX9690SIM125-A
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.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 left common carotid artery using a benchmark bmx96 access system (benchmark max), benchmark 6f 071 delivery catheter (benchmark), non-penumbra guidewire, and non-penumbra sheath.It was noted that the patient¿s anatomy was tortuous.During the procedure, the sheath was first inserted into the patient; however, the physician decided to exchange the sheath for a benchmark max.Subsequently, while inserting the benchmark max over a dilator to access the radial artery, the physician experienced resistance and damaged the distal tip of the benchmark max.Therefore, it was removed.The physician then attempted to use a benchmark to navigate the guidewire to the target vessel; however, it was unsuccessful.It should be noted that there was no alleged deficiency or damage to the benchmark.The physician decided to end the procedure at this point.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned benchmark max confirmed a distal tip ovalization.If the device is advanced against resistance during use, damage such as this may occur.During functional testing, the returned dilator was able to advance through the benchmark max without issue.The root cause of the resistance experienced during the procedure could not be determined.Penumbra catheters 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.Section h.Box 6.Conclusions code 1: 4316 - the investigation findings do not lead to a clear conclusion about the cause of resistance.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: 11326277
• Report Number: 3005168196-2021-00277
• Device Sequence Number: 793206
• Product Code: DQY
• UDI-Device Identifier: 00815948022652
• UDI-Public: 00815948022652
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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): 01/19/2021
• 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: 10/26/2023
• Device Model Number: BMX9690SIM125-A
• Device Catalogue Number: BMX9690SIM125
• Device Lot Number: F101483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2021
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 03/10/2021
• Initial Report FDA Received Date: 02/14/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005