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

Model Number	BMK6F105
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
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.
Event or Problem Description
The patient was undergoing a medical procedure in the anterior cerebral artery (aca) to treat two aneurysms using a benchmark 6f 071 delivery catheter (benchmark), a non-penumbra microcatheter, a non-penumbra femoral sheath and guidewires.During the procedure, after the physician performed a diagnostic angiography, the physician positioned the benchmark in the cervical internal carotid artery using a guidewire.The physician advanced the microcatheter over a guidewire to the anterior cerebral artery.The physician then planned to position the benchmark distally in the internal carotid artery with the help of the microcatheter and guidewire.Once the physician reached the carotid bifurcation with the microcatheter and microwire, the physician attempted to position the benchmark distally in the internal carotid artery.However, the physician noticed that the benchmark was no longer visible via fluoroscopy.The physician noticed that the benchmark had broken with the distal end of the benchmark in the carotid and the other part of the benchmark in the aortic arch.Afterwards, the physician attempted to remove the microcatheter but noticed that the microcatheter was stuck inside the benchmark.Therefore, the physician removed the whole system together.It was reported that while the whole system was being removed under constant fluoroscopy it looked like the distal end of the benchmark moved separately from the rest of the benchmark.The procedure was completed using a long sheath and an intermediate catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned benchmark revealed, that the catheter was fractured.And the complaint was confirmed.If the benchmark is forcefully mishandled during use, damage such as a kink may occur.Further manipulation of a kinked device may worsen to a fracture.Further evaluation revealed, a kink and ovalization in the distal fractured segment.This damage was incidental to the reported complaint.And may have occurred from handling, during the procedure and packaging for return.Penumbra products are visually 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.

• Brand Name: BENCHMARK 6F 071 DELIVERY CATHETER
• Common Device Name: DQY
• 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: 12685261
• Report Number: 3005168196-2021-02361
• Device Sequence Number: 11726497
• Product Code: DQY
• UDI-Device Identifier: 00814548014012
• UDI-Public: 00814548014012
• Combination Product (Y/N): Y
• Initial Reporter Country: HU
• PMA/510(K) Number: K142321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2021
• 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: 04/27/2024
• Device Model Number: BMK6F105
• Device Catalogue Number: BMK6F105
• Device Lot Number: F105800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• 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: 09/23/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 10/22/2021
• Supplement Report FDA Received Date: 11/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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: 55 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005