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

Catalog Number	BMK6F95BER120
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the right internal carotid artery (ica) using a benchmark 6f 071 delivery catheter (benchmark), a neuron select catheter 5f (5f select), a non-penumbra short sheath, and a guidewire.During the procedure, the physician successfully placed the benchmark in the ica via femoral artery access using the short sheath, 5f select and guidewire.The physician then noticed that the proximal end of the benchmark was leaking saline.Therefore, the benchmark was removed.The procedure was completed using a new benchmark and the same 5f select.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
Evaluation of the returned benchmark confirmed a leak on the proximal end.While flushing the benchmark during decontamination, the device leaked from underneath the strain relief.Evaluation revealed a kink near the hub underneath the strain relief, and a hole was present in the catheter.This is likely contributing to the leak and typically occurs if the device is gripped by the hub and is manipulated at angles during use.Further evaluation revealed bends and kinks along the length of the benchmark.This damage was incidental to the complaint and likely occurred during packaging for 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.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the follow-up #01 and is being corrected on this follow-up #02 mfr report: 3005168196-2024-00333.1.Section h.Box 10./11.Narrative/corrected data.Evaluation of the returned benchmark confirmed a leak on the proximal end.While flushing the benchmark during decontamination, the device leaked from underneath the strain relief.Evaluation revealed a kink near the hub underneath the strain relief, and a hole was present in the catheter.This is likely contributing to the leak and typically occurs if the device is gripped by the hub and is manipulated at angles during use.Further evaluation revealed bends and kinks along the length of the benchmark.This damage was incidental to the complaint and likely occurred during packaging for 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.Note: based on the investigation findings, this is not considered a reportable event.This event did not and, if it were to recur, it would not cause or contribute to serious deterioration or death.

• 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: 20345567
• Report Number: 3005168196-2024-00333
• Device Sequence Number: 8062225
• Product Code: DQY
• UDI-Device Identifier: 00814548014128
• UDI-Public: 00814548014128
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K212838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2024
• 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 Catalogue Number: BMK6F95BER120
• Device Lot Number: F00010394
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 10/10/2024; Not provided
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/06/2024; 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2024
• 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: 67 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005