BOSTON SCIENTIFIC CORPORATION EMERGE; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
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Model Number 7133 |
Device Problems
Difficult to Advance (2920); Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/01/2019 |
Event Type
malfunction
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Event Description
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Reportable based on additional information received on 17apr2019.It was reported that tracking difficulties were encountered and shaft kink occurred.The 95% stenosed target lesion was located in the left anterior descending artery.Two 3.5mm x 15mm quantum maverick balloon catheters and two 2.00mm x 15mm emerge balloon catheters were advanced and used during this procedure.However, the balloons were entangled with the guidewire and the delivery shafts were kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, additional information was received that the balloons were entrapped on the guide wire and became stuck together.Finally, the devices were removed successfully.
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Manufacturer Narrative
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Device evaluated by mfr.: returned product consisted of an emerge balloon catheter.The shaft, hypotube, tip and balloon were microscopically and visually examined.There was blood in the inflation lumen and balloon.The balloon was loosely folded.There was a kink in the shaft 117.8cm distal from the strain relief.Microscopic inspection revealed tip damage.The device was prepped with an inflation device filled with water and connected to the inflation port to inflate the device.A pinhole leak was detected near the distal marker band.The marker band was inspected, and no damage was found.Inspection of the remainder of the device presented no other damage or irregularities.
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Event Description
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Reportable based on additional information received on 17apr2019.It was reported that tracking difficulties were encountered and shaft kink occurred.The 95% stenosed target lesion was located in the left anterior descending artery.Two 3.5mm x 15mm quantum maverick balloon catheters and two 2.00mm x 15mm emerge balloon catheters were advanced and used during this procedure.However, the balloons were entangled with the guidewire and the delivery shafts were kinked.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.However, additional information was received that the balloons were entrapped on the guide wire and became stuck together.Finally, the devices were removed successfully.
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