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

Catalog Number	BMK6F105
Medical Device Problem Codes	Fracture (1260); Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The patient was undergoing a medical procedure in the innominate artery using a benchmark 6f 071 delivery catheter (benchmark), non-penumbra sheath (6fr), non-penumbra glidecath, and a guidewire.It was reported that the patient's arteries were small.During the procedure, a 6f sheath was placed in the radial artery and medication was administered.The physician obtained central access using the glidecath with a guidewire.The guidewire was then used to exchange from the glidecath to a benchmark; however, while advancing the benchmark into the innominate artery, the physician experienced resistance.The physician attempted to retract the benchmark without the wire but had difficulty.The physician then attempted to use a kelly clamp to remove the benchmark, but the benchmark had fractured and began to unravel.The proximal end of the benchmark was removed from the sheath using the kelly clamp.The physician accessed the groin and used a snare device to remove the fractured distal end of the benchmark from the groin.The procedure was completed using new devices.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 a fracture on the distal shaft and revealed stretching proximal to the fractured location.If the device is retracted against resistance, damage such as stretching, and a fracture may occur.The patient¿s small arteries reported in the complaint may have contributed to resistance experienced during the procedure.Further evaluation revealed ovalizations, an additional stretch and fracture on the distal shaft.This damage was incidental to the complaint and likely occurred during removal of the fractured segment using clamp and snare device.Penumbra catheters are inspected during in-process inspection and during quality inspection after manufacturing.The product lot number was not provided; therefore, the manufacturing records could not be reviewed.

• 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: 20260807
• Report Number: 3005168196-2024-00322
• Device Sequence Number: 12937624
• Product Code: DQY
• UDI-Device Identifier: 00815948025141
• UDI-Public: 00815948025141
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 10/04/2024
• 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 Catalogue Number: BMK6F105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2024
• 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: 08/26/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 46 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005