MAUDE Adverse Event Report: PENUMBRA, INC. BENCHMARK 6F 071 DELIVERY CATHETER; DQY, QJP

Catalog Number	BMK6F95BER120
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was undergoing a medical procedure in the left middle cerebral artery (mca) using a benchmark delivery 6f 071 catheter (benchmark), a non-penumbra sheath (6f short), and a guidewire.It was noted that the patient¿s anatomy was tortuous, and the arteries were narrow.During the procedure, the physician was unable to gain access to the target vessel with non-penumbra catheters.Next, while advancing a benchmark through the common carotid artery to the mca, the physician experienced resistance and the benchmark became stuck.When attempting to remove the benchmark, the physician found it would not retract and one to one movement was lost.The patient was given nitroglycerin and verapamil; however, the benchmark remained stuck.The physician attempted to remove the benchmark a third time, and, subsequently, fractured the benchmark mid-shaft.The distal portion of the benchmark remained in the patient¿s vessel.The patient was transported to the operating room (or) for surgical removal of the fractured portion of the benchmark via cutdown surgery.
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.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 24jan24: 1.Section b.Box 5.Describe event or problem.Please note that this complaint was submitted to the fda by the user facility with the following reference number:mw5149731.The following sections are being updated based on additional information included in the user facility report submitted to the fda: 1.Section b.Box 5.Describe event or problem.2.Section e.Box 4.Initial reporter also sent report to fda.3.Section g.Box 3.Report source.Device evaluation: evaluation of the returned benchmark confirmed that the catheter was fractured.Evaluation revealed stretching on multiple locations of the returned device including the fracture site.This indicated that the fracture likely occurred due to retraction against resistance.If the benchmark is retracted against resistance, damage such as stretching and subsequent fracture may occur.It was reported that the patient¿s anatomy was tortuous, and the arteries were narrow.This may have contributed to the resistance during the procedure.Additional stretching and fractures were observed on the benchmark.Some of this damage may have been incidental to the reported complaint and occurred during removal of the devices from the kinked non-penumbra sheath or for packaging for return.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.
Event or Problem Description
The patient was undergoing a medical procedure in the left middle cerebral artery (mca) using a benchmark delivery 6f 071 catheter (benchmark), a neuron select catheter 5f (5f select), a non-penumbra sheath (6f short), and a guidewire.It was noted that the patient¿s anatomy was tortuous, and the arteries were narrow.During the procedure, the physician was unable to gain access to the target vessel with non-penumbra catheters.Next, while advancing a benchmark over a 5f select through the common carotid artery to the mca, the physician experienced resistance and the benchmark became stuck.When attempting to remove the benchmark, the physician found it would not retract and one to one movement was lost.It was reported that a vasospasm occurred in the vessel and the patient was given nitroglycerin and verapamil.The physician attempted to remove the benchmark a third time, and, subsequently, fractured the benchmark mid-shaft.The proximal portion of the benchmark was removed, and the fractured distal portion of the benchmark remained in the patient¿s vessel.It was reported the 5f select was stuck in the proximal portion of the benchmark.The physician attempted to remove the distal portion of the benchmark with a balloon angioplasty device; however, the attempt was unsuccessful.The patient was transported to the operating room (or) for surgical removal of the fractured portion of the benchmark via cutdown.

• Brand Name: BENCHMARK 6F 071 DELIVERY CATHETER
• 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: 18548386
• Report Number: 3005168196-2024-00028
• Device Sequence Number: 7946001
• Product Code: DQY
• UDI-Device Identifier: 00815948025189
• UDI-Public: 815948025189
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K212838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/27/2026
• Device Catalogue Number: BMK6F95BER120
• Device Lot Number: F00008230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• 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: 12/24/2023
• Supplement Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 01/19/2024
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005