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

Catalog Number	BMK6F115
Medical Device Problem Codes	Fracture (1260); Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2024
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.H3 other text : placeholder.
Event or Problem Description
The patient was undergoing a medical procedure to treat an aneurysm in the internal carotid artery (ica) using a benchmark 6f 071 delivery catheter (benchmark), a non-penumbra sheath, and a guidewire.During the procedure, while advancing the benchmark through the sheath, the physician experienced resistance and the benchmark would not advance further.The physician then observed under fluoroscopy that the distal length of the benchmark had unraveled.Therefore, the benchmark was removed.The procedure was completed using another catheter and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned benchmark confirmed that the catheter was fractured and revealed unraveling of the internal coil winds at the fractured location.If the benchmark is advanced against resistance, damage such as a kink and subsequent fracture may occur.Further evaluation revealed an additional fracture on the catheter shaft, kinks and ovalization throughout the length of the catheter.This damage was incidental to the reported complaint.If the ovalization was present during the procedure, it may have contributed to the reported resistance.The root cause of the additional fracture and kinks on the device 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.

• 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: 19105399
• Report Number: 3005168196-2024-00142
• Device Sequence Number: 7766567
• Product Code: DQY
• UDI-Device Identifier: 00814548014098
• UDI-Public: 814548014098
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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
• Report Date (Section B): 06/06/2024
• 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: 07/06/2025
• Device Catalogue Number: BMK6F115
• Device Lot Number: F00001944
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 05/24/2024
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/07/2022
• 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: 24 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005