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

Catalog Number BMK6F115

Device Problems Fracture (1260); Unraveled Material (1664); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2024

Event Type  malfunction  

Manufacturer Narrative

This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.H3 other text : placeholder.

Event Description

The patient was undergoing a medical procedure to treat an aneurysm in the internal carotid artery (ica) using a benchmark 6f 071 delivery catheter (benchmark), a non-penumbra sheath, and a guidewire.During the procedure, while advancing the benchmark through the sheath, the physician experienced resistance and the benchmark would not advance further.The physician then observed under fluoroscopy that the distal length of the benchmark had unraveled.Therefore, the benchmark was removed.The procedure was completed using another catheter and the same sheath.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned benchmark confirmed that the catheter was fractured and revealed unraveling of the internal coil winds at the fractured location.If the benchmark is advanced against resistance, damage such as a kink and subsequent fracture may occur.Further evaluation revealed an additional fracture on the catheter shaft, kinks and ovalization throughout the length of the catheter.This damage was incidental to the reported complaint.If the ovalization was present during the procedure, it may have contributed to the reported resistance.The root cause of the additional fracture and kinks on the device could not be determined.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.H3 other text : placeholder.

• Brand Name: BENCHMARK 6F 071 DELIVERY CATHETER
• Type of Device: 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: 19105399
• MDR Text Key: 340155952
• Report Number: 3005168196-2024-00142
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548014098
• UDI-Public: 814548014098
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K212838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,04/15/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: BMK6F115
• Device Lot Number: F00001944
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Female