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

Model Number 5MAXJET7KIT

Device Problems Fluid/Blood Leak (1250); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2020

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.This report is associated with mfr report number: 3005168196-2021-00122.

Event Description

The patient was undergoing a thrombectomy procedure in the middle cerebral artery (mca) using a penumbra system jet7 reperfusion catheter (jet7), a penumbra system 3max reperfusion catheter (3maxc) and a neuron max 6f 088 long sheath (neuron max).During the procedure, while attempting to insert the jet7 into the neuron max after flushing, it was noticed that the metal strain relief near the hub was broken.Therefore, the jet7 was removed.The physician then used a 3maxc through the neuron max to bring a new jet7 to the target vessel.After completing several passes, the jet7 was noticed to be leaking and the mid-shaft of the jet7 was found to be kinked.Therefore, the jet7 was removed.The procedure was completed using a new aspiration catheter, the same 3maxc and the same neuron max.There was no report of an adverse effect to the patient.

Manufacturer Narrative

Evaluation of the first returned jet7 confirmed that while flushing the device during decontamination, a leak was observed coming from beneath the strain relief.The strain relief was unraveled, and the device was found to be fractured.If the device is retracted from its packaging at an extreme angle or is otherwise mishandled during use, damage such as this may occur.Evaluation of the second returned jet7 confirmed a kink in the mid-shaft that leaked while flushing the device during decontamination.If the device is manipulated against resistance or is otherwise mishandled during use, damage such as a kink may occur.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.This report is associated with mfr report number: 3005168196-2021-00122.H3 other text : placeholder.

Manufacturer Narrative

Please note that the following section was incorrectly reported on the initial mfr report and is being corrected on this follow-up #02 mfr report.1.Section g.Box 5.510(k).This report is associated with mfr report number: 1.3005168196-2021-00122.

• 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: 11202824
• MDR Text Key: 227948413
• Report Number: 3005168196-2021-00123
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00814548019925
• UDI-Public: 00814548019925
• Combination Product (y/n): Y
• 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: Initial,Followup,Followup
• Report Date: 01/01/2005,01/19/2022

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: 08/05/2023
• Device Model Number: 5MAXJET7KIT
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F99322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• 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: 12/22/2020
• Initial Date FDA Received: 01/20/2021
• Supplement Dates Manufacturer Received: 02/22/2021; 01/14/2005
• Supplement Dates FDA Received: 03/17/2021; 01/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2020
• 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: 88 YR
• Patient Sex: Male