MAUDE Adverse Event Report: PENUMBRA, INC. PENUMBRA SYSTEM JET7 REPERFUSION CATHETER; NRY

Catalog Number 5MAXJET7

Device Problems Fracture (1260); Leak/Splash (1354)

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

Event Date 12/26/2023

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 thrombectomy procedure in the right internal carotid artery (ica) using a penumbra system jet7 reperfusion catheter (jet7), neuron max 6f 088 long sheath (neuron max), and a guidewire.During the procedure, the physician noticed that the proximal end of the jet7 was fractured and leaking after completing the first pass.Therefore, the jet7 was removed.The procedure was completed using another aspiration catheter and the same neuron max.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the returned jet7 confirmed a leak coming from underneath the strain relief.If the device is manipulated against resistance or at an angle, damage such as a kink and a subsequent fracture near the hub may occur.Further evaluation revealed kinks on the distal shaft, and the distal tip was shaped.The shaped distal tip may have contributed to resistance.The kinks on the distal shaft may have also occurred during advancement against resistance during the procedure.Penumbra devices 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.H3 other text : placeholder.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Type of Device: NRY
• 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: 18862338
• MDR Text Key: 337708718
• Report Number: 3005168196-2024-00075
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548019857
• UDI-Public: 814548019857
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K173761
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,04/10/2024

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 Expiration Date: 05/17/2024
• Device Catalogue Number: 5MAXJET7
• Device Lot Number: C31494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• 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: 02/08/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 03/07/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2021
• 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