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

Catalog Number	BMK6F95BER120
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a medical procedure using a benchmark 6f 071 delivery catheter (benchmark) and a 6f non-penumbra short sheath.During the procedure, the physician was in the process of inserting the benchmark into a 6f short sheath; however, upon attaching the benchmark to be flushed, the physician noticed it to be leaking proximal to the hub.Therefore, the benchmark was removed.The procedure was completed using a new benchmark.There was no report of an 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 near the hub.Evaluation revealed, a fracture underneath the strain relief near the hub.If the benchmark is mishandled at an extreme angle, during use, damage such as a kink and subsequent fracture may occur.This damage likely contributed to the leak observed, during the procedure and evaluation.Further evaluation of the device revealed, an ovalization on the distal shaft.This damage was likely incidental to the complaint.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: 15612032
• Report Number: 3005168196-2022-00475
• Device Sequence Number: 20620282
• 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): 11/03/2022
• 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: BMK6F95BER120
• Device Lot Number: F00001948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2022
• 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: 09/22/2022
• Supplement Date Received by Manufacturer: 10/18/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 11/03/2022
• 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: 78 YR
• Patient Sex: Female
• Patient Weight: 56 KG
• Date Report Sent to FDA: 01/01/2005