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

Model Number	5MAXJET7B-A
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012); Suction Failure (4039)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the internal carotid artery using a penumbra system jet7 reperfusion catheter (jet7), a neuron max 6f 088 long sheath (neuron max) and a non-penumbra stent retriever.During the procedure, while advancing the jet7 through the neuron max to the target location for the first pass, the physician experienced resistance.Once the jet7 was at the target location, aspiration was initiated; however, the aspiration failed.Subsequently, it was noticed that the distal end of the jet7 was broken.Therefore, the physician decided to remove the jet7.While removing the jet7, the physician experienced resistance; however, the jet7 was removed successfully.The procedure was completed using a new jet7, the same neuron max and the same stent retriever.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Evaluation of the returned jet7 confirmed that the catheter was fractured.If the jet7 is retracted against resistance, damage such as stretching and subsequent fracture may occur.The solitaire mentioned in the complaint may have contributed to the stretching on the jet7 prior to the fracture.Based on the returned damage and reported complaint, the device was likely damaged further during and after removal from the patient.Further evaluation revealed that the catheter had kinks along the catheter shaft.This damage was incidental to the reported complaint and the root cause could not be determined.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
• 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: 12872441
• Report Number: 3005168196-2021-02688
• Device Sequence Number: 5748842
• Product Code: NRY
• UDI-Device Identifier: 00815948023239
• UDI-Public: 00815948023239
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K173761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2022
• 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: 02/11/2024
• Device Model Number: 5MAXJET7B-A
• Device Catalogue Number: 5MAXJET7B
• Device Lot Number: F103848
• 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 to Manufacturer: 01/10/2005
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2021
• 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: 64 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/01/2005