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

Model Number	5MAXJET7KIT
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2020
Type of Reportable Event	Malfunction
Additional 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: 3005168196-2021-00123.
Event or Problem 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.
Additional 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: 3005168196-2021-00123.
Additional 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:3005168196-2021-00122.1.Section g.Box 5.510(k).This report is associated with mfr report number: 1.3005168196-2021-00123.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Common Device Name: 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: 11202799
• Report Number: 3005168196-2021-00122
• Device Sequence Number: 16711903
• Product Code: NRY
• UDI-Device Identifier: 00814548019925
• UDI-Public: 00814548019925
• Combination Product (Y/N): Y
• Initial Reporter Country: GM
• PMA/510(K) Number: K173761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2022
• Report Date (Section F): 01/01/2005

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/14/2022
• Device Model Number: 5MAXJET7KIT
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F93661
• 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 to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 12/22/2020
• Supplement Date Received by Manufacturer: 02/22/2021; 01/14/2005
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 03/17/2021; 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005