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

Catalog Number	BMK6F105BER130
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left internal carotid artery (ica) using a benchmark 6f 071 delivery catheter (benchmark), a non-penumbra select catheter, a non-penumbra sheath and a guidewire.During the procedure, the physician placed the benchmark in the target vessel with the guidewire and select catheter.Upon removing the select catheter, the physician noticed that the benchmark appeared to be unwinding.Therefore, the physician was able to manually pull and removed the benchmark successfully.The procedure was completed using a new benchmark and the same sheath.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.H3 other text : placeholder.
Additional Manufacturer Narrative
Evaluation of the returned benchmark confirmed coil winds were exposed coming out of the hub.Evaluation revealed that a coil wind may have been exposed within the hub.Manipulation of a device within the benchmark may cause the exposed coil wind to start unraveling.The root cause of the coil wind becoming exposed could not be determined.Penumbra devices are visually 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.
Additional Manufacturer Narrative
Please note that the following sections were inadvertently missed on the follow-up #01 and are being included on this follow-up #02 mfr report:3005168196-2023-00509.1.Section h.Box 6.Conclusions code 1.
Additional Manufacturer Narrative
Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #03 mfr report:3005168196-2023-00509.

• 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: 18120372
• Report Number: 3005168196-2023-00509
• Device Sequence Number: 7512694
• Product Code: DQY
• UDI-Device Identifier: 00815948025226
• UDI-Public: 00815948025226
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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,Followup,Followup
• Report Date (Section B): 06/13/2024
• 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: 07/31/2026
• Device Catalogue Number: BMK6F105BER130
• Device Lot Number: F00007750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• 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: 10/19/2023
• Supplement Date Received by Manufacturer: 11/14/2023; 01/14/2005; 01/14/2005
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 12/07/2023; 04/18/2024; 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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: 48 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005