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

Catalog Number	BMK6F105
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The patient was undergoing a coil embolization procedure in the internal carotid artery (ica) using a benchmark 6f 071 delivery catheter (benchmark), a non-penumbra sheath, an angio-catheter, and a guidewire.During the procedure, the benchmark was advanced through a sheath and resistance was encountered while advancing the benchmark through the aorta.While removing the benchmark, the physician inadvertently broke the benchmark at the proximal end while retracting it through the hub of the sheath.However, the benchmark remained intact and was completely removed from the patient by hand.The procedure was completed using another benchmark and the same non-penumbra sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned benchmark confirmed a fracture.Evaluation revealed a kink and yield marks distal to the fractured location.This indicated that the device was likely kinked prior to the fracture.If the benchmark is retracted at an angle, damage such as kinks and subsequent fracture may occur.Based on the reported event, this damage likely occurred during retraction of the catheter through the hub of the sheath.Further evaluation of the device revealed ovalization on the distal shaft.The root cause of this damage could not be determined; however, this damage likely contributed to the reported resistance experienced during advancement.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.

• 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: 16080683
• Report Number: 3005168196-2022-00601
• Device Sequence Number: 15026374
• Product Code: DQY
• UDI-Device Identifier: 00814548014012
• UDI-Public: 814548014012
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2023
• 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2025
• Device Catalogue Number: BMK6F105
• Device Lot Number: F00001772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2022
• 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: 12/07/2022
• Supplement Date Received by Manufacturer: 12/30/2022
• Initial Report FDA Received Date: 12/30/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• 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: 87 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005