|
Catalog Number P4030 |
Device Problems
Material Integrity Problem (2978); Material Protrusion/Extrusion (2979)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 08/22/2017 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device evaluation summary: the silverhawk device was returned for evaluation.No ancillary devices were included.The silverhawk was inspected and observed the orange guidewire tubing was protruding out from the distal assembly.The torque shaft guidewire tubing showed a zipper tear throughout the component.No tearing of the orange tubing was noted, however a bend of approximately 45degrees was noted.A 0.014" guidewire from the lab was attempted to be back-loaded.Verified the tear occurred throughout the whole section of the torque shaft guidewire tubing.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
The physician used a silverhawk directional atherectomy device to treat a plaque lesion in the right mid sfa.The lesion was described as having little calcification, 80 mm in length with 80% stenosis.The artery was 6 mm in diameter with little tortuosity.The device was prepped as per the ifu with no issues identified.A 0.014"non-medtronic guidewire was used with a 6 fr non-medtronic sheath.No embolic protection was used.It was reported upon removal of the device, a wire was noted to be hanging from the working portion of the device along the nosecone or cutter window.No resistance was experienced during advancement or withdrawal.No patient injury was reported.
|
|
Search Alerts/Recalls
|
|
|