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

Catalog Number	BMK6F95BER120
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient underwent a coil embolization procedure in the anterior communicating artery (acom) using a benchmark 6f 071 delivery catheter (benchmark) and a non-penumbra catheter.After successful completion of the procedure, the physician removed the benchmark out from the patient and noticed the benchmark was leaking at the proximal end.The procedure had ended at this point and a computed tomography (ct) performed to confirm there was no air embolus.There was no report of an adverse effect to the patient.
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.
Additional Manufacturer Narrative
Evaluation of the returned benchmark confirmed a leak on the proximal end.Evaluation revealed a fracture and kinks underneath the strain relief.If the benchmark is manipulated at an angle during use, damage such as a kink and subsequent fracture may occur.During evaluation, the benchmark was flushed, and a leak was observed coming from underneath the strain relief.The fracture likely contributed to the reported leak.Further evaluation revealed bends along the length of the catheter shaft.This damage was incidental to the reported complaint and likely occurred during packaging of the device for return.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.

• Brand Name: BENCHMARK 6F 071 DELIVERY CATHETER
• Common Device Name: DQY
• 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: 16659392
• Report Number: 3005168196-2023-00148
• Device Sequence Number: 17957825
• Product Code: DQY
• UDI-Device Identifier: 00814548014128
• UDI-Public: 814548014128
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 04/10/2023
• 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: 09/19/2025
• Device Catalogue Number: BMK6F95BER120
• Device Lot Number: F00003117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• 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: 02/19/2023
• Supplement Date Received by Manufacturer: 03/24/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2022
• 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: 88 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005