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

Catalog Number	BMK6F105BER130
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal carotid artery using a benchmark 6f 071 delivery catheter (benchmark), a non-penumbra guide sheath and a microcatheter.It was noted that the patient''s anatomy was tortuous.During the procedure, the physician advanced the benchmark through the guide sheath by gaining transradial access.While attempting to adjust the benchmark, the physician pulled the benchmark back.While retracting the benchmark further, the physician noticed under fluoroscopy that the benchmark had stopped retracting and was fractured.The physician then removed the benchmark and the guide sheath together.Upon removal, the guide sheath was cut by the physician to visualize where the benchmark was fractured.It was reported that the benchmark was fractured at the mid-shaft but still connected by the coil winds.The procedure was completed by gaining femoral access with a new sheath and a new benchmark.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
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: 3005168196-2023-00535.1.Section b.Box 5.Describe event or problem.Evaluation of the returned benchmark revealed a fracture on the proximal shaft.This is likely the reported mid-shaft fracture.If the device is retracted against resistance, damage such as a fracture may occur.Further evaluation of the returned benchmark revealed kinks along the proximal fractured segment, and the distal fractured segment was returned still inserted through the non-penumbra hva and guide catheter, and the guide catheter was kinked in multiple locations and was clamped by forceps.If the parent catheter was damaged during the procedure, it may have contributed to resistance during manipulation of the benchmark.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.
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 #02 mfr report:3005168196-2023-00535 1.Section d.Box 4.Unique identifier.

• 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: 18243357
• Report Number: 3005168196-2023-00535
• Device Sequence Number: 7116154
• Product Code: DQY
• UDI-Device Identifier: 00815948025226
• UDI-Public: 00815948025226
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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: 08/14/2026
• Device Catalogue Number: BMK6F105BER130
• Device Lot Number: F00007991
• 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: 11/10/2023
• Supplement Date Received by Manufacturer: 01/19/2024; 01/14/2005
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 02/02/2024; 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• 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: 66 YR
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/01/2005