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

Catalog Number	BMK6F95M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.Please note that this complaint was submitted to the fda by the user facility with the following reference number: (b)(4).H3 other text: placeholder.
Event or Problem Description
The patient was undergoing a pipeline embolization procedure in the left internal carotid artery (ica) using a benchmark 6f 071 delivery catheter (benchmark), a non-penumbra pipeline embolization device and a sheath.During the procedure, the radial access was gained, and the benchmark was advanced.The physician then noticed the hub of the benchmark was cracked and air was going into the system.Therefore, the benchmark was removed, and a non-penumbra catheter was used.It was reported that the physician aborted the procedure after the non-penumbra pipeline embolization device failed to expand.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was disposed of and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.

• 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: 17624879
• Report Number: 3005168196-2023-00404
• Device Sequence Number: 7302098
• Product Code: DQY
• UDI-Device Identifier: 00814548014166
• UDI-Public: 814548014166
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2023
• 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: 12/28/2025
• Device Catalogue Number: BMK6F95M
• Device Lot Number: F00004797
• Was Device Available for Evaluation?: No
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2022
• 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: 69 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005