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

Catalog Number BMK6F105

Device Problems Break (1069); Physical Resistance/Sticking (4012)

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

Event Date 12/06/2022

Event Type  malfunction  

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 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.

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
• 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: 16080683
• MDR Text Key: 308447929
• Report Number: 3005168196-2022-00601
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 01/01/2005,01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• 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 Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2022
• 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: 87 YR
• Patient Sex: Female