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Model Number VEL160STR-A
Device Problem Break (1069)
Patient Problems Intracranial Hemorrhage (1891); Vascular Dissection (3160)
Event Date 08/25/2020
Event Type  Injury  
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 numbers: 3005168196-2020-01508, 3005168196-2020-01509.
Event Description
The patient was undergoing a thrombectomy procedure in the m1 segment of the left middle cerebral artery (mca) using a velocity delivery microcatheter (velocity), penumbra system jet 7 reperfusion catheter (jet7), penumbra system ace 68 reperfusion catheter (ace68), neuron max 6f 088 long sheath (neuron max), neuron select catheter 6f (6f select), and a non-penumbra sheath (8f). It was noted that the patient¿s anatomy was tortuous. During the procedure, the physician used an 8fr sheath for femoral access and then advanced a neuron max and a 6f select to access the left common carotid artery. Next, a guidewire and velocity were used to access the left internal carotid artery. It was reported that the patient was moving significantly during the procedure. The physician made multiple passes under manual syringe aspiration with an ace68 and with a jet7. After a manual aspiration attempt through the jet7, the physician re-inserted the velocity into the jet7 and noticed the velocity would not advance out the distal tip of the jet7. Subsequently, the physician noticed the distal portion of the velocity had broken off upon previously removing it out from the jet7 and remained in the m1. The physician then used a snare device and stent retriever (solitaire) to remove the distal portion of the velocity. It was also reported that the patient continued to move significantly during removal of the distal portion of the velocity. The physician attempted to intubate the patient which induced vomiting. It was reported that both ace68 and jet7 became kinked during the multiple passes due to the patient¿s movements and tortuous anatomy. The procedure was completed using a new velocity and the same neuron max. Post procedure, fluoroscopic images revealed no extravasation. The following day, a computed tomography (ct) scan revealed evidence of vessel injury and bleeding. The relationship between the vessel injury and bleeding to the velocity is unknown.
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Type of DeviceDQY
Manufacturer (Section D)
one penumbra place
alameda CA 94502
Manufacturer Contact
veronica farris
one penumbra place
alameda, CA 94502
MDR Report Key10552506
MDR Text Key207510805
Report Number3005168196-2020-01507
Device Sequence Number1
Product Code DQY
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/01/2005,08/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberVEL160STR-A
Device Catalogue NumberVEL160STR
Device Lot NumberF97294
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/01/2005
Event Location No Information
Date Report to Manufacturer01/10/2005
Date Manufacturer Received12/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial