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

Model Number	5MAXJET7BKIT-A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2021-00322.
Event or Problem Description
The patient was undergoing a thrombectomy procedure using a penumbra system jet 7 reperfusion catheter (jet7), a penumbra system 3max reperfusion catheter (3maxc), a neuron max 6f 088 long sheath (neuron max), and a guidewire.During the procedure, a jet7 became kinked; therefore, the jet7 was removed.Later, the same issue occurred with a second jet7; therefore, the second jet7 was removed.The procedure was completed using the same 3maxc and the same neuron max.It is unknown whether another jet7 was used to complete the procedure.There was no report of an adverse effect to the patient.

• Brand Name: PENUMBRA SYSTEM JET7 REPERFUSION CATHETER
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11362087
• Report Number: 3005168196-2021-00323
• Device Sequence Number: 19668916
• Product Code: NRY
• UDI-Device Identifier: 00815948023246
• UDI-Public: 00815948023246
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K173761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/26/2021
• 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 Model Number: 5MAXJET7BKIT-A
• Device Catalogue Number: 5MAXJET7BKIT
• Was Device Available for Evaluation?: No
• 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: 01/26/2021
• Initial Report FDA Received Date: 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Date Report Sent to FDA: 01/01/2005