MAUDE Adverse Event Report: PENUMBRA, INC. NEURON MAX 6F 088 LONG SHEATH; DQY

Model Number	PNML6F088904
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2019
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.This report is associated with mfr report number: 3005168196-2019-02067.
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 kit (kit) and a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician placed a neuron max in the radial artery to the cervical internal carotid artery (ica).Next, the physician advanced a triaxial system consisting of a penumbra system jet 7 reperfusion catheter (jet7), non-penumbra microcatheter and a non-penumbra guidewire through the neuron max.The patient began coughing and thrashing uncontrollably and the physician converted from a monitored anesthesia care (mac) to a general anesthesia.After the patient was intubated, the physician removed the microcatheter and guidewire but not without difficulty.It was discovered that the metal radiopaque marker band from the microcatheter had pinched off and embolized distally into the right anterior cerebral artery (aca).The physician then attempted to remove the jet7 from the patient; however, it was discovered that the neuron max had kinked causing the jet7 to fracture.Therefore, a non-penumbra balloon catheter was advanced into the neuron max along the side of the fractured portion of the jet7.The physician then inflated the balloon and safely removed the jet7 and neuron max.It was reported that the broken marker band of the microcatheter was left in the patient.The physician then closed the radial artery and proceeded the procedure with groin access.After several attempts to remove the clot from the m1 segment using non-penumbra devices, reperfusion was not achieved.
Additional Manufacturer Narrative
Results: the neuron max was kinked approximately 23.0 and 78.0 cm from the hub.The distal fractured portion of the jet7 was inside the neuron max.Conclusions: evaluation of the returned neuron max confirmed a distal kink.This type of damage likely occurred due to the reported coughing and thrashing of the patient during the procedure.The distal fractured portion of the jet7 was stuck inside the distal kink of the neuron max.Further evaluation of the neuron max revealed proximal kinks that were likely incidental to the reported complaint.Evaluation of the returned jet7 confirmed a fracture.If the catheter is forcefully retracted against resistance a fracture can occur.This damage likely occurred due retraction against resistance due to the kinked neuron max.This is further supported by the distal fractured portion of the jet7 being returned within the neuron max kink.Evaluation of the non-penumbra microcatheter confirmed that the device was damaged and the marker band was missing.Penumbra catheters are visually 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.Section h.Box 6.Conclusions code 1: 4316 - the patient coughing and thrashing may have contributed to the device malfunction.This report is associated with mfr report number: 3005168196-2019-02067.

• Brand Name: NEURON MAX 6F 088 LONG SHEATH
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 9288232
• Report Number: 3005168196-2019-02066
• Device Sequence Number: 2003199
• Product Code: DQY
• UDI-Device Identifier: 00814548012179
• UDI-Public: 00814548012179
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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
• Report Date (Section B): 10/10/2019
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2022
• Device Model Number: PNML6F088904
• Device Catalogue Number: PNML6F088904
• Device Lot Number: F91093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 02/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Date Report Sent to FDA: 01/01/2005