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

Catalog Number	BMK6F105
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a medical procedure in the internal carotid artery (ica) using a benchmark 6f 071 delivery catheter (benchmark).During the procedure, the physician noticed the benchmark was leaking near the proximal end.Therefore, the benchmark was removed.The procedure was completed using a new benchmark.There was no report of an adverse effect to that patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.
Additional Manufacturer Narrative
Please note that the following sections are being updated based on additional information provided by a penumbra sales representative on 11/15/2023: section b.Box 5.Describe event or problem; section g.Box 4.Date received by manufacturer.
Event or Problem Description
The patient was undergoing a medical procedure in the internal carotid artery (ica) using a benchmark 6f 071 delivery catheter (benchmark) and a guidewire.During the procedure, the physician placed the benchmark in the patient and then noticed that the proximal end of the benchmark was leaking.Therefore, the benchmark was removed.The procedure was completed using a new benchmark.There was no report of an adverse effect to that patient.
Additional Manufacturer Narrative
Evaluation of the returned benchmark confirmed a leak near the proximal end.Evaluation revealed that the benchmark was kinked at the proximal end and had a hole at the kinked location underneath the strain relief.This damage likely contributed to the reported leak.If the device is held at an angle during advancement, damage such as this may occur.Further evaluation revealed ovalization at the distal end of the catheter.This damage is incidental to the reported complaint and likely occurred after removal from the procedure.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.
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 # 3 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: 18074773
• Report Number: 3005168196-2023-00496
• Device Sequence Number: 18058730
• Product Code: DQY
• UDI-Device Identifier: 00814548014012
• UDI-Public: 00814548014012
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,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: 06/07/2026
• Device Catalogue Number: BMK6F105
• Device Lot Number: F00007095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/09/2023
• Supplement Date Received by Manufacturer: 10/05/2023; 12/13/2023; 01/14/2005
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 12/16/2023; 01/12/2024; 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2023
• 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 Sex: Unknown
• Date Report Sent to FDA: 01/01/2005