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

Model Number	BMK6F95MBER120
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2022
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 medical procedure in the right transverse sinus using a benchmark delivery catheter (benchmark), a select catheter, a guidewire, a neuron select catheter 5f (5f select), a non-penumbra sheath, and a stent system.It was reported that the patient¿s anatomy was tortuous.During the procedure, the physician advanced the benchmark through the sheath and over the 5f select to the target vessel.Next, the physician experienced slight resistance while advancing the guidewire and the stent system through the benchmark from the sigmoid to the transverse sinus but was able to reach the target vessel.After advancing the stent system in the target vessel, the physician noticed that the distal end of the benchmark had fractured.The physician then retracted the entire system down in the inferior vena cava (ivc) with the stent system in the distal end of the benchmark.After that, the physician used a goose neck snare device (25mm) through the left femoral vein to remove the broken part of the benchmark through the left groin.It was reported that the proximal end of the benchmark and stent system were removed from the right groin.Subsequently, while advancing a new stent system through a new benchmark to the target vessel, the physician experienced slight resistance from the sigmoid to the transverse sinus.While adjusting the stent device in the correct location, the physician noticed that the benchmark was stretching.Therefore, the physician removed the benchmark with the stent system inside.The procedure was completed using new non-penumbra catheter and a new stent system.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that this complaint was submitted to the fda by the user facility with the following reference numbers: mw5106690 h3 other text : placeholder.
Additional Manufacturer Narrative
Evaluation of the returned benchmark confirmed a distal shaft fracture and revealed stretching near the fractured location.This indicates that the benchmark was stretched prior to fracture.If the benchmark is manipulated against resistance, it may become stretched and subsequently fracture.Further evaluation revealed that the guidewire was outside of the guidewire lumen of the non-penumbra stent device and kinked.This may have contributed to the resistance experienced while advancing the stent device through the benchmark.Further evaluation also revealed ovalization on the fractured distal shaft.This damage likely occurred when snaring the device for removal from the patient.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.

• Brand Name: BENCHMARK 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: 13472751
• Report Number: 3005168196-2022-00046
• Device Sequence Number: 16572411
• Product Code: DQY
• UDI-Device Identifier: 00814548014173
• UDI-Public: 00814548014173
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K142321
• 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
• Report Date (Section B): 04/04/2022
• 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: 09/14/2024
• Device Model Number: BMK6F95MBER120
• Device Catalogue Number: BMK6F95MBER120
• Device Lot Number: F109147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• 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: 01/12/2022
• Supplement Date Received by Manufacturer: 03/14/2022; 03/14/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 03/17/2022; 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2021
• 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: 36 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005