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

Catalog Number	BMX9680BER105-A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing an embolization procedure in the internal carotid artery (ica) using a benchmark bmx96 access system (benchmark max), a neuron select catheter 5f (5f select), and a guidewire.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician advanced the bmx96 over the guidewire and 5f select.Subsequently, after 30 minutes of use and completing an angiogram, the bmx96 was noticed to be leaking.Therefore, the benchmark was removed.After removal, the physician found the bmx96 to be fractured mid-shaft.The procedure was completed using a new bmx96.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Additional Manufacturer Narrative
Evaluation of the returned bmx96 revealed that the catheter was kinked and a leak at the kinked location.This is likely reported damage.If the bmx96 is manipulated at an extreme angle during use, damage such as a kink may occur.The bmx96 was flushed during evaluation and bubbles were observed coming from the kinked location.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.

• 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: 15439820
• Report Number: 3005168196-2022-00433
• Device Sequence Number: 5569636
• Product Code: DQY
• UDI-Device Identifier: 00815948022638
• UDI-Public: 815948022638
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201271
• 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): 11/01/2022
• 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: 03/27/2025
• Device Catalogue Number: BMX9680BER105-A
• Device Lot Number: H12817
• 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: 08/26/2022
• Supplement Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 09/16/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2022
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005