MAUDE Adverse Event Report: PENUMBRA, INC. NEURON SELECT CATHETER 5F; DQY

Model Number PNS5F130SIM

Device Problems Material Too Rigid or Stiff (1544); Physical Resistance/Sticking (4012)

Patient Problem Vascular Dissection (3160)

Event Date 03/23/2021

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.Potential adverse events in the labeling with the neuron intracranial access system include, but are not limited to, dissection or perforation, vessel spasm, thrombosis, intracranial hemorrhage, distal embolization, emboli, ischemia, including death.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report number: 3005168196-2021-01151.

Event Description

The patient was undergoing a thrombectomy procedure in the vertebral artery using neuron select catheter 5f (5f select), a neuron max 6f 088 long sheath (neuron max), and a guidewire.During the procedure, while advancing the 5f select through the neuron max over the guidewire, the physician experienced resistance and, subsequently, noticed there was a dissection in the vertebral artery.Therefore, the 5f select, the neuron max, and the guidewire were removed.It was reported by the physician that the 5f select was ¿stiffer¿ than usual upon removal.The procedure ended at this point.It was reported by the physician that the vessel dissection was related to the 5f select and neuron max.It should be noted that there was no clinical outcome related to the vessel dissection and no action was taken to treat the dissection of the vertebral artery.Post-procedure, a thrombus formation was noted in the right femoral artery and was reported to be related to the neuron max.

Manufacturer Narrative

Please note that the following section was inadvertently missed on the initial mfr report and is being updated on this follow-up # 01 mfr report:3005168196-2021-01150.1.Section b.Box 2.Outcomes attributed to adverse event.This report is associated with mfr report number: 1.3005168196-2021-01151.

• Brand Name: NEURON SELECT CATHETER 5F
• Type of Device: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 11874785
• MDR Text Key: 253304226
• Report Number: 3005168196-2021-01150
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00814548010236
• UDI-Public: 00814548010236
• Combination Product (y/n): Y
• PMA/PMN Number: K083125
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PNS5F130SIM
• Device Catalogue Number: PNS5F130SIM
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other