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

Model Number	BMK6F95BER120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned benchmark confirmed a leak coming from near the hub beneath the stain relief.During decontamination, the device was flushed with the bleach solution, and the solution was observed exiting the catheter from beneath the strain relief.The device was then flushed with air while submerged in the solution, and air was observed exiting the catheter from the same location.Further evaluation revealed that upon unraveling the strain relief, the device was kinked, and a hole was present beneath the strain relief.Probable cause of this damage may be forceful mishandling of the device at extreme angles during 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the middle cerebral artery (mca) using a benchmark 6f 071 delivery catheter (benchmark), non-penumbra catheter, a non-penumbra sheath, and a t connector.During the procedure, the physician placed the non-penumbra sheath in the origin of the left internal carotid artery.Next, the physician advanced the benchmark containing the non-penumbra catheter in the carotid siphon, the non-penumbra catheter was then removed.Subsequently, when the physician closed the t connector, blood was noticed to be leaking between the hub and the metal reinforcement segment of the benchmark.Therefore, the benchmark was removed.The procedure was completed using a new benchmark and the same sheath.There was no report of an adverse effect to the patient.

• Brand Name: BENCHMARK DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 12550282
• Report Number: 3005168196-2021-02159
• Device Sequence Number: 4032021
• Product Code: DQY
• UDI-Device Identifier: 00814548014128
• UDI-Public: 00814548014128
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K142321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/29/2021
• 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: 04/06/2024
• Device Model Number: BMK6F95BER120
• Device Catalogue Number: BMK6F95BER120
• Device Lot Number: F105231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• 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: 09/03/2021
• Initial Report FDA Received Date: 09/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005