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Model Number P4044 |
Device Problems
Device Damaged by Another Device (2915); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/17/2021 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Physician attempted to use a silverhawk btk atherectomy device with a 6fr non-medtronic sheath and 0.
014 non-medtronic guidewire during treatment of an 80mm soft tissue cto (chronic total occlusion-100%) in the patient¿s mid right popliteal artery.
Slight vessel calcification is reported.
Artery diameter reported as 4mm.
Ifu was followed.
The vessel was not pre-dilated.
It is reported that after running the device and pulled out of the body, a black string like substance was encountered coming out of the cutter window.
The observed material appeared to be fibrous.
Unclear if this was part of the device.
The device was not wiped down between insertions.
The cutter was inside housing when removed.
When removed from patients, all parts of device were accounted for.
The device was removed safely.
A replacement hawk one device was opened to complete the procedure.
No patient injury reported.
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Search Alerts/Recalls
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