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

Catalog Number	BMK6F95M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the returned benchmark confirmed that the catheter was fractured.Evaluation also revealed that the non-penumbra sheath was ovalized and had bend along its length.If the benchmark is manipulated against resistance, damage such as a fracture may occur.Based on the reported complaint, the root cause of resistance could not be determined.Further evaluation revealed an additional fracture and a kink in the catheter shaft.This damage was incidental to the reported complaint and the root cause 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.H3 other text: placeholder.
Event or Problem Description
The patient was undergoing a medical procedure using a benchmark 6f 071 delivery catheter (benchmark), a 6f short sheath, a 5fr diagnostic catheter, and a guidewire.During the procedure, the physician placed the short sheath into the patient.After performing diagnostic angiograms, the physician advanced the benchmark to the origin of the subclavian artery using the guidewire.While advancing the diagnostic catheter through the benchmark, the physician noticed under fluoroscopy that the distal end of the diagnostic catheter was parallel to the distal end of the benchmark.Subsequently, the physician noticed under fluoroscopy that the mid-shaft of the benchmark was fractured in the abdominal aorta.Therefore, the diagnostic catheter and the proximal part of the benchmark were removed.After a few attempts, the physician successfully removed the distal part of the benchmark using a snare device.The procedure was completed using a new benchmark, a new 6f short sheath, and the same guidewire.There was no report of an adverse effect to the patient.

• 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: 17074184
• Report Number: 3005168196-2023-00270
• Device Sequence Number: 6841895
• Product Code: DQY
• UDI-Device Identifier: 00814548014166
• UDI-Public: 814548014166
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/06/2023
• 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: 10/26/2025
• Device Catalogue Number: BMK6F95M
• Device Lot Number: F00003833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• 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: 05/11/2023
• Initial Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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: 74 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005