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

Catalog Number	BMX9690BER125
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2023
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 anterior communicating artery (acomm) using a benchmark bmx96 access system (bmx96).During the procedure, the physician was experiencing resistance while advancing the bmx96 through the right radial artery.It was reported that the physician continued to advance the bmx96 against resistance and was able to get the bmx96 into the aortic arch.Subsequently, the bmx96 would not advance any further and the physician decided to abort the radial access and remove the bmx96.While retracting the bmx96, the physician again experienced resistance and fractured the proximal end of the bmx96.Therefore, the physician used a clamp to remove the remaining exposed bmx96 and upon pulling it further, the distal end of the bmx96 had broken into two separate pieces.The physician then obtained femoral access and used a snare device to remove the broken distal end of the bmx96.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 that the catheter was fractured.This damage typically occurs during retraction of the device against resistance.It was reported that the device was advanced against resistance during the procedure and subsequently retracted against the same resistance.The root cause of the resistance could not be determined.If the bmx96 is retracted against resistance during use, damage such as stretching and subsequent fracture may occur.Evaluation revealed additional kinks, fractures and ovalization in multiple locations along the catheter shaft.This fractures were reported to have occurred during removal attempts from the radial artery prior to snaring from a femoral access point.The complaint indicated that the bmx96 was clamped to remove the exposed bmx96 causing several of the ovalizations observed on the returned device.The kinks on the returned device were likely due to repeated manipulation against resistance during advancement and retrieval attempts.Further evaluation revealed stretching at the distal end of the catheter.This may have occurred during initial retraction attempt or during snaring for removal.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: 17252277
• Report Number: 3005168196-2023-00317
• Device Sequence Number: 4795365
• Product Code: DQY
• UDI-Device Identifier: 00815948022645
• UDI-Public: 815948022645
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/12/2023
• 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: 09/19/2025
• Device Catalogue Number: BMX9690BER125
• Device Lot Number: H00001162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• 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: 06/12/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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: 56 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005