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

Model Number	PNML6F088904-R
Medical Device Problem Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Please note that this complaint was submitted to the fda by the user facility with the following reference number: uf/importer report #: ( b)(4).Results: the neuron max was kinked approximately 85.0 cm from the hub.Conclusions: evaluation of the returned jet7 confirmed a fracture at its distal shaft and revealed stretching proximal to the fracture.If the jet7 is forcefully retracted against resistance, damage such as this may occur.Further evaluation of the device revealed ovalizations and multiple kinks on the catheter.This damage was likely incidental to the complaint.Evaluation of the returned neuron max revealed a distal kink.The root cause of this damage could not be determined; however, this damage may have contributed to the resistance experienced while retracting the jet7 during the procedure.During functional testing, a demonstration jet7 was able to advance through the neuron max with resistance due to the kink on the neuron max.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: 3005168196-2020-01887.
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 jet 7 reperfusion catheter (jet7), a neuron max 6f 088 long sheath (neuron max), and a guidewire.It was noted that the patient¿s anatomy was tortuous.During the procedure, the physician completed one pass using the jet7 and neuron max.While removing the jet7, the physician experienced resistance due to the patient's anatomy; therefore, the physician pulled both neuron max and jet7 slightly to eliminate any tension in the system.After this, the jet7 was removed.Upon removal, it was noticed that the distal tip of the jet7 had broken off.Therefore, the physician obtained left femoral access in anticipation of needing to snare.However, upon removal of the neuron max, the physician noticed that the distal tip of the jet7 was lodged in the neuron max.The procedure ended at this point and thrombolysis in cerebral infarction (tici) grade 3 recanalization was achieved.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: 10980247
• Report Number: 3005168196-2020-02230
• Device Sequence Number: 2974700
• Product Code: DQY
• UDI-Device Identifier: 00815948022393
• UDI-Public: 00815948022393
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• 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): 11/09/2020
• 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: 07/06/2023
• Device Model Number: PNML6F088904-R
• Device Catalogue Number: PNML6F088904
• Device Lot Number: H10591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• 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: 11/09/2020
• Initial Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Date Report Sent to FDA: 01/01/2005