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

Catalog Number	BMK6F105BER130
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned benchmark confirmed a leak near the hub and revealed a fracture underneath the strain relief.If the device is gripped by the hub and is lifted at an angle, damage such as a kink and subsequent fracture may occur.Further evaluation revealed multiple kinks and ovalizations along the length of the device.This damage was not mentioned in the reported complaint and the root cause could not be determined.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 coil embolization procedure in the posterior communicating artery (pca) using a benchmark 6f 071 delivery catheter (benchmark), a neuron select catheter 5f (5f select), and a guidewire.During the procedure, the physician advanced the benchmark into the internal carotid artery (ica) using the 5f select and the guidewire.Upon removal of the 5f select and guidewire, the physician attached a contrast line to the hub of the benchmark and noticed a leak.The physician then realized that the benchmark was fractured at the proximal length, near the hub.Therefore, the benchmark was removed.The procedure was completed using a new benchmark, the same 5f select, and the same guidewire.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note, that the following section was incorrectly reported on the initial mfr report.And is being corrected on this follow-up # 1 mfr report: 1.Section d.Box 4.Unique identifier.H3 other text: placeholder.

• 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: 18381840
• Report Number: 3005168196-2023-00569
• Device Sequence Number: 18046594
• Product Code: DQY
• UDI-Device Identifier: 00814548014029
• UDI-Public: 00814548014029
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K212838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2026
• Device Catalogue Number: BMK6F105BER130
• Device Lot Number: F00006762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• 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: 11/27/2023
• Supplement Date Received by Manufacturer: 01/14/2005
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2023
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005