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

Model Number	5MAXJET7KIT
Medical Device Problem Codes	Break (1069); Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2021
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 using a penumbra system jet7 reperfusion catheter (jet7) and a penumbra engine (engine).During the procedure, after using the jet7 under aspiration for approximately ten minutes, the physician decided to remove the jet7.Upon removal, it was noticed that the distal end of the jet7 was partially frayed.No additional information regarding the completion of the procedure was provided.There was no report of an adverse effect to the patient.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a penumbra system jet7 reperfusion catheter (jet7), a penumbra engine (engine) and a sheath.During the procedure, the physician completed three passes using the jet7.During the fourth pass after using the jet7, the physician noticed that no thrombus was being aspirated through the jet7.Subsequently, it was noticed that the distal end of the jet7 was partially frayed.Therefore, the jet7 was removed.The procedure was completed using another catheter, the same engine and the same sheath.There was no report of an adverse effect to the patient.
Additional Manufacturer Narrative
Please note that the following section is being updated based on additional information provided by a penumbra sales representative on 10/12/2021: 1.Section b.Box 5.Describe event or problem please note that the device associated with this complaint was expected to be returned; however, additional information received from the penumbra sales representative indicated that the device was discarded and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.H3 other text : placeholder.
Additional Manufacturer Narrative
Please note, that the following section was inadvertently missed on the follow-up #01 mfr report.And is being updated on this follow-up # 02 mfr report.1.Section h: box 6, device code 2.H3 other text: placeholder.

• 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: 12542574
• Report Number: 3005168196-2021-02150
• Device Sequence Number: 11787753
• Product Code: NRY
• UDI-Device Identifier: 00814548019925
• UDI-Public: 00814548019925
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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): 11/27/2021
• 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: 09/22/2022
• Device Model Number: 5MAXJET7KIT
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: F93241
• Was Device Available for Evaluation?: No
• 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: 08/30/2021
• Supplement Date Received by Manufacturer: 10/12/2021; 01/14/2005
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 11/10/2021; 11/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2019
• 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: 72 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/01/2005