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

Model Number	PNML6F088904-R
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2020
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 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 numbers: 3005168196-2020-01134, 3005168196-2020-01135.
Event or Problem Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the middle cerebral artery (mca) using a neuron max 6f 088 long sheath (neuron max), a penumbra system jet 7 reperfusion catheter (jet7) and a velocity delivery microcatheter (velocity).It was noted that the patient had type iii arch and an anatomy that was very tortuous.During the procedure, the physician advanced the neuron max until it was unable to be advanced beyond the carotid bifurcation.It was noted that the takeoff of the brachiocephalic artery was very tortuous.The physician then advanced the velocity over the jet7 beyond the brachiocephalic artery; but eventually was unable to advance them any further.The physician made several attempts to advance the velocity and jet7 further but were unsuccessful.The physician experienced resistance while attempting to retract the velocity and jet7.Upon removal, it was noticed that the jet7 stretched and the distal tip had broken off.The physician confirmed that the broken piece of the jet7 was lodged within the distal end of the neuron max; therefore, the neuron max containing the broken piece of the jet7 was removed.Upon removal it was noticed that the neuron max was kinked.It was reported that the physician attempted to continue the procedure using a new neuron max, a new jet7 and a new velocity, but was unsuccessful.The physician then attempted to complete the procedure using radial access; however, it was also unsuccessful.It was reported that the attempts were unsuccessful due to how difficult it was to access the target vessel.There was no report of an adverse effect to the patient.

• 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: 10381151
• Report Number: 3005168196-2020-01133
• Device Sequence Number: 11552316
• Product Code: DQY
• UDI-Device Identifier: 00815948022393
• UDI-Public: 00815948022393
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• 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
• Report Date (Section B): 07/16/2020
• 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: 03/16/2023
• Device Model Number: PNML6F088904-R
• Device Catalogue Number: PNML6F088904
• Device Lot Number: H10381
• 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: 07/16/2020
• Initial Report FDA Received Date: 08/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/01/2005