MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX; NRY

Model Number	PNML6F0881004
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Death (1802); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/26/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.This report is associated with mfr report number: 3005168196-2019-01443.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right m1 segment of the middle cerebral artery (mca) using a penumbra system jet7 reperfusion catheter (jet7) and a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician reported that the patient had tortuous anatomy.The physician experienced resistance while advancing the jet7 and velocity through the neuron max.After completing two passes, it was reported that resistance was experienced while advancing and retracting the jet7 and subsequently the jet7 fractured within the patient's vessel.The neuron max containing the broken jet7 was removed and the tip of the jet7 was left in the m1 artery.Upon removal of the neuron max, a kink was observed.The procedure was concluded at this point.It was reported that the patient passed away; however, the cause of death is unknown at this time.Furthermore, the relationship between the fractured jet7 tip and death is unknown.
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 mfr report: describe event or problem.Results: the returned neuron max was found kinked at approximately 88.5cm from the hub, and minor damage was observed at approximately 111.0cm from the hub.The total length of the device is approximately 113.5cm.The distal portion of the jet7 was stuck inside the neuron max at the kink.Conclusions: evaluation of the returned jet7 confirmed a stretched and fractured device.It was reported that resistance was experienced while advancing and retracting the jet7.If the jet7 is forcefully retracted against resistance, it may begin to stretch and eventually fracture.The distal portion of the jet7 was stuck inside the neuron max, at the kinked location.The neuron max kink likely contributed to the resistance experienced during the procedure while advancing and retracting the jet7.Evaluation of the returned neuron max confirmed a kink.During functional testing, a demonstration mandrel was unable to pass through the kink due to the remaining distal portion of the jet7 being stuck inside the lumen of the neuron max.The root cause of the neuron max kink was unable to be determined.A kinked device will likely result in additional resistance when advancing or retracting devices through it.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: 3005168196-2019-01443.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the right m1 segment of the middle cerebral artery (mca) using a penumbra system jet7 reperfusion catheter (jet7), neuron max 6f 088 long sheath (neuron max), velocity delivery microcatheter (velocity), and penumbra system 3d revascularization device (psr3d).It was reported that the patient had tortuous anatomy.During the procedure, the physician experienced resistance while advancing the jet7 and velocity through the neuron max.After completing two passes, it was reported that resistance was experienced while advancing and retracting the jet7 and subsequently the jet7 fractured.The neuron max containing the broken jet7 was removed from the patient.Upon removal of the neuron max, a kink was observed.The procedure was concluded at this point.It was reported that the patient then later expired; however, the cause of death is unknown.
Additional Manufacturer Narrative
Please note that the following sections were updated on this follow-up #02 mfr report 3005168196-2019-01444: 1.Section b.Box 1.Adverse event and/or product problem.2.Section b.Box 2.Outcomes attributed to adverse event; date of death.3.Section h.Box 1.Type of reportable event.4.Section h.Box 6.Patient code 2.This report is associated with mfr report number: 1.3005168196-2019-01443 h3 other text : placeholder.

• Brand Name: NEURON MAX
• Common Device Name: NRY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 8829330
• Report Number: 3005168196-2019-01444
• Device Sequence Number: 2864202
• Product Code: NRY
• UDI-Device Identifier: 00814548012292
• UDI-Public: 00814548012292
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K111380
• 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,Followup,Followup
• Report Date (Section B): 06/26/2019
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2020
• Device Model Number: PNML6F0881004
• Device Catalogue Number: PNML6F0881004
• Device Lot Number: F77031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 11/14/2019; 01/14/2005
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 12/09/2019; 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Date Report Sent to FDA: 01/01/2005