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U.S. Department of Health and Human Services

Medsun Reports
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Type of Device:
Catheter For Crossing Total Occlusions
Device Brand Name:
Pioneer Plus Catheter
Device Manufacturer's Name:
PHILIPS VOLCANO
Date of this Report:
(mm/dd/yyyy)
03/01/2022
Describe the Event
or Problem:
After one use of the IVUS (Intravascular Ultrasound) catheter, it would not flush. The catheter was removed and replaced without incident or harm to the patient.
the device(s) may have
caused or contributed to:
Potential for patient harm
Minor injury to the patient or health care provider
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