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

Catalog Number	BMK6F105M
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a benchmark 6f 071 delivery catheter (benchmark), a non-penumbra catheter, and a guidewire.During the procedure, the physician experienced resistance while advancing the benchmark over the catheter and guidewire.The physician found that the benchmark was fractured at the mid-shaft and therefore, the benchmark was removed.No additional information was provided regarding the completion of the procedure.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by the distributor on 10/17/2023: 1.Section b.Box 5.Describe event or problem evaluation of the returned benchmark confirmed a fracture at the mid-shaft and revealed kinks near the fracture.If the device is advanced against resistance, damage such as kinks and a subsequent fracture may occur.Evaluation also revealed a kink and ovalization along the distal end.If the peel-able sheath is not used to protect the distal end of the benchmark during advancement, damage such as ovalization may occur.This damage may have contributed to resistance during advancement.Further evaluation also revealed a kink near the hub.This damage was likely incidental to the complaint and may have occurred during return to penumbra.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.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the cerebral artery using a benchmark 6f 071 delivery catheter (benchmark), a non-penumbra catheter, and a guidewire.During the procedure, the physician experienced resistance while advancing the benchmark over the guidewire.The physician noticed that blood was leaking from one side of the benchmark and subsequently found that the benchmark was fractured at the mid-shaft.Therefore, the benchmark was removed.The procedure was completed using a new benchmark, the same catheter, 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 inadvertently missed on the follow-up #01 mfr report and is being included on this follow-up #02 mfr report:3005168196-2023-00465.1.Section h.Box 6.Conclusions code 1 h3 other text : placeholder.
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 #01 mfr report:3005168196-2023-00465.1.Section d.Box 4.Unique identifier h3 other text : placeholder.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the follow-up #03 and is being corrected on this follow-up #04 mfr report:.1.Section h.Box 10./11.Narrative/corrected data (incorrectly referenced follow up #01).

• 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: 17940954
• Report Number: 3005168196-2023-00465
• Device Sequence Number: 12371028
• Product Code: DQY
• UDI-Device Identifier: 00814548014043
• UDI-Public: 00814548014043
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K212838
• 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,Followup,Followup,Followup
• Report Date (Section B): 06/13/2024
• 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: 04/09/2026
• Device Catalogue Number: BMK6F105M
• Device Lot Number: F00006312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2023
• 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: 09/18/2023
• Supplement Date Received by Manufacturer: 10/19/2023; 01/14/2005; 01/14/2005; 01/14/2005
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 11/08/2023; 11/22/2023; 06/12/2024; 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2023
• 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: 56 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005