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

Model Number	PNML6F088904M
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2019
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: 3005168196-2019-02078.
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 ace 64 reperfusion catheter (ace64) and a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician advanced the neuron max into the internal carotid artery (ica) followed by the ace64.Upon advancement of the ace64, the physician met unusual resistance.An angiogram was performed and the physician visualized that the diameter of the ace64 was too small and that the neuron max may have kinked mid-shaft.The physician decided to remove the ace64 and replace it with a larger catheter; however, the physician encountered resistance when the ace64 was retracted a few centimeters back into the neuron max.Subsequently, the ace64 became stuck and broke in the neuron max.The distal part of the ace64 remained in the neuron max, therefore, the neuron max and broken ace64 were removed together from the patient.It was reported that, upon removal of the neuron max, no kink was found.However, the procedure was completed using a new neuron max and a penumbra system 5max ace reperfusion catheter (5max ace).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) using a penumbra system ace 64 reperfusion catheter (ace64) and a neuron max 6f 088 long sheath (neuron max).During the procedure, the physician advanced the neuron max into the internal carotid artery (ica) followed by the ace64.While advancing the ace64, the physician met unusual resistance.An angiogram was performed and the physician visualized that the diameter of the ace64 was too small and that the neuron max may have kinked mid-shaft.The physician decided to remove the ace64; however, encountered resistance while withdrawing.Subsequently, the ace64 became stuck and broke in the neuron max.The distal part of the ace64 remained in the neuron max, therefore, the neuron max and broken ace64 were removed together from the patient.It was reported that, upon removal of the neuron max, no kink was found.However, the procedure was completed using a new neuron max and a penumbra system 5max ace reperfusion catheter (5max ace).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: 3005168196-2019-02079 1.Section b.Box 5.Common device name please note that the device associated with this complaint was expected to be returned; however, the device was lost in transit and is no longer available for return.Therefore, 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 number: 1.3005168196-2019-02078.

• 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: 9303023
• Report Number: 3005168196-2019-02079
• Device Sequence Number: 1864165
• Product Code: DQY
• UDI-Device Identifier: 00814548012162
• UDI-Public: 00814548012162
• Combination Product (Y/N): Y
• Initial Reporter Country: AU
• PMA/510(K) Number: K111380
• 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): 10/14/2019
• 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: 05/16/2022
• Device Model Number: PNML6F088904M
• Device Catalogue Number: PNML6F088904M
• Device Lot Number: F90372
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/10/2005
• Initial Date Received by Manufacturer: 10/14/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 01/21/2020
• 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