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

Catalog Number 5MAXJET7KIT

Device Problem Fracture (1260)

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

Event Date 01/12/2024

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 thrombectomy procedure in the right m1 segment of the middle cerebral artery (mca) using a penumbra system jet7 reperfusion catheter (jet7), a neuron max 6f 088 long sheath (neuron max), a penumbra system red 68 reperfusion catheter (red68), a stent retriever, and a guidewire.It was noted that the patient had elongated and calcified vessels.During the procedure, the physician attempted to advance the red68 with the stent retriever using the neuron max to the target location.However, due to the difficulty and unsuccessful placement of the red68, the physician decided to switch the red68 for a jet7.The physician successfully advanced the jet7 using the neuron max to the target location on the second attempt.The physician then initiated aspiration for approximately three to four minutes.The jet7 was then retracted under aspiration.Upon removal, the physician noticed that the distal length of the jet7 was fractured.The physician then used the guidewire and the neuron max to remove the fractured jet7.The physician decided to end the procedure at this point.It was reported that the patient expired on 14jan2024 due to a media infarction.The physician reported the damage to the jet7 was not related to the media infarction or the patient''s death.

Manufacturer Narrative

Evaluation of the returned jet7 confirmed a fracture on the distal shaft.Further evaluation revealed stretching proximal to the fracture and an ovalization distal to the fracture.If the device is retracted against resistance, damage such as stretching, and a fracture may occur.The root cause of resistance during the procedure could not be determined.Further evaluation revealed additional kinks along the device.This damage was incidental to the complaint and may have occurred during removal of the device from the procedure or during packaging for return to penumbra.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: 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: 18696653
• MDR Text Key: 335262020
• Report Number: 3005168196-2024-00050
• Device Sequence Number: 1
• Product Code: NRY
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: Followup
• Report Date: 01/01/2005,03/31/2024

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: 04/04/2024
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: C00006667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: Not provided
• Initial Date FDA Received: 02/13/2024
• Supplement Dates Manufacturer Received: 03/01/2024
• Supplement Dates FDA Received: 03/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2021
• 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
• Patient Age: 71 YR
• Patient Sex: Male