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

Catalog Number	BMX9690BER125
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2023
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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a medical procedure in the left middle cerebral artery (mca) using a bmx96 access system (bmx96), a non-penumbra sheath, a non-penumbra catheter (vtk), and a guidewire.During the procedure, the physician advanced the sheath through the common femoral artery (cfa) to the thoracic aorta.It was reported the patient¿s anatomy was tortuous.Next, a guidewire along with the catheter was advanced to the left carotid artery.The physician then attempted to advance the bmx96 over the catheter; subsequently, a kink and a small hole was noticed on the proximal end of the bmx96.Therefore, the bmx96 was not used for the remainder of the procedure.The procedure was completed using a new bmx96.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned bmx96 confirmed a kink and hole was present on the catheters proximal end.If the device is manipulated against resistance during use, damage such as this may occur.Based on the reported complaint, the patient¿s anatomy was tortuous.This may have contributed to resistance during the procedure.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.Note: based on the investigation findings, this is not considered a reportable event.This event did not and, if it were to recur, it would not cause or contribute to serious deterioration or death.

• 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: 16834765
• Report Number: 3005168196-2023-00205
• Device Sequence Number: 6034226
• Product Code: DQY
• UDI-Device Identifier: 00815948022645
• UDI-Public: 815948022645
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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
• Report Date (Section B): 07/18/2023
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/24/2025
• Device Catalogue Number: BMX9690BER125
• Device Lot Number: H00001382
• 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: 04/03/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 04/28/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• 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: 68 YR
• Patient Sex: Unknown
• Patient Weight: 186 KG
• Date Report Sent to FDA: 01/01/2005