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

Model Number	5MAXJET7KIT
Medical Device Problem Codes	Break (1069); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/29/2019
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 m1 segment of the middle cerebral artery (mca), a1 segment of the anterior cerebral artery (aca) using a penumbra system jet 7 reperfusion catheter (jet7), neuron max 6f 088 long sheath (neuron max), and guidewire.During the procedure, the physician attempted to advance the jet7 and the neuron max over the guidewire to the target vessel; however the neuron max dropped down into the aortic arch twice and the jet7 would not advance beyond the ophthalmic artery.Therefore, the jet7 and the neuron max were removed.Upon removal it was noticed that the jet7 was broken around the mid-shaft.The procedure was completed using a non-penumbra aspiration catheter.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)/a1 segment of the anterior cerebral artery (aca) using a penumbra system jet 7 reperfusion catheter (jet7), neuron max 6f 088 long sheath (neuron max), and guidewire.During the procedure, the physician experienced resistance while advancing the jet7 over the guidewire through the neuron max.It was reported that the neuron max dropped down into the aortic arch twice and the jet7 would not advance beyond the ophthalmic artery.The physician then noticed under fluoroscopy that the jet7 was broken; therefore, the jet7 was removed.Upon removal, it was noted that the jet7 was broken around the mid-shaft and held together by a nitinol wire.The procedure was completed using a non-penumbra aspiration catheter and the same neuron max.There was no report of an adverse effect to the patient.
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 #01 mfr report:3005168196-2020-00099.Results: the returned jet7 was fractured at approximately 16.0 cm from the hub.The device was kinked at approximately 17.0 cm and 116.0 cm from the hub.Conclusions: evaluation of the returned jet7 confirmed a fracture in its proximal shaft and revealed a kink near the fracture.If the jet7 is forcefully advanced against resistance, it may become kinked.If the kinked device is further manipulated, the kink may worsen to a fracture.The neuron max used in the procedure was not returned for evaluation; therefore, the root cause of the resistance could not be determined.Further investigation of the device revealed a distal kink.This kink was likely incidental to the complaint.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
• MDR Report Key: 9629199
• Report Number: 3005168196-2020-00099
• Device Sequence Number: 2884599
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2020
• 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: 04/01/2022
• Device Model Number: 5MAXJET7KIT
• Device Catalogue Number: 5MAXJET7KIT
• Device Lot Number: C17732
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 01/03/2020
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 01/24/2020
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Date Report Sent to FDA: 01/01/2005