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

Catalog Number	BMK6F105MBER130
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2023
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left vertebral artery using a benchmark 6f 071 delivery catheter (benchmark) and a guidewire.During the procedure, the physician had difficulty advancing the benchmark over a guidewire to the target vessel due to the patient¿s anatomy being difficult with elongated vessels.After several attempts, the physician successfully advanced the benchmark over the guidewire to the target vessel.Afterwards, the guidewire would not rotate slightly as expected.Therefore, the physician decided to remove the benchmark and guidewire.While removing the benchmark, the physician experienced resistance and subsequently fractured the proximal end of the benchmark.The benchmark was removed and no longer used in the procedure.The physician was completed using another catheter.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section was updated on this follow-up #01 mfr report: 3005168196-2023-00233: 1.Section b.Box 5.Describe event or problem evaluation of the returned benchmark confirmed a fracture on the proximal end.Evaluation also revealed kinks on the proximal end, and an ovalization near the distal tip.If the device is advanced against resistance, damage such as kinks may occur.Subsequently, if the device is retracted against resistance, damage such as a fracture may occur.It was reported that the patient¿s anatomy was difficult to access due to elongated vessels.This may have contributed to resistance during the procedure and the ovalization on the distal end.Penumbra products 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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the left vertebral artery using a benchmark 6f 071 delivery catheter (benchmark) and a guidewire.During the procedure, the physician had difficulty advancing the benchmark over a guidewire to the target vessel due to the patient¿s anatomy being difficult with elongated vessels.After several attempts, the physician successfully advanced the benchmark over the guidewire to the target vessel.Afterwards, the guidewire would not rotate slightly as expected.Therefore, the physician decided to remove the benchmark and guidewire.While removing the benchmark, the physician experienced resistance and subsequently fractured the proximal end of the benchmark outside the patient.The entire benchmark was then pulled out of the patient by hand and no additional intervention was required.The physician was completed using another catheter.There was no report of an adverse effect to the patient.

• 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: 16962397
• Report Number: 3005168196-2023-00233
• Device Sequence Number: 5243665
• Product Code: DQY
• UDI-Device Identifier: 00814548014050
• UDI-Public: 814548014050
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K142321
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2023
• 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: 09/25/2025
• Device Catalogue Number: BMK6F105MBER130
• Device Lot Number: F00003201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 04/24/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 05/19/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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 Sex: Male
• Date Report Sent to FDA: 01/01/2005