Model Number D2201 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Thrombosis (2100); Urinary Retention (2119); Complaint, Ill-Defined (2331)
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Event Date 04/29/2019 |
Event Type
Injury
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Event Description
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It was reported that six days post a convective radiofrequency water vapor thermal therapy procedure of the prostate, the patient had a heart attack.It is unsure what the symptoms were but it was noted that the patient was straining to urinate and had bowel movement.The patient received a cardiac stent, anticoagulation therapy, and surgery for a suprapubic catheter due to a blood clot in the bladder.The patient was in and out of icu over the last 3 weeks and reported to have had surgery again (unknown cause) at 21 days post the index procedure.No further information is available.
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Event Description
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It was reported that six days post a convective radiofrequency water vapor thermal therapy procedure of the prostate, the patient had a heart attack.It is unsure what the symptoms were but it was noted that the patient was straining to urinate and had bowel movement.The patient received a cardiac stent, anticoagulation therapy, and surgery for a suprapubic catheter due to a blood clot in the bladder.The patient was in and out of icu over the last 3 weeks and reported to have had surgery again (unknown cause) at 21 days post the index procedure.No further information is available.
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Manufacturer Narrative
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Patient code corrected from thrombosis 2100 to hematoma 1884.
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Manufacturer Narrative
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The device is not available for analysis.A review of the rezum ifu and operators manual was completed and did not reveal any evidence of device misuse, off-label use, or failure to follow instructions.The potential cause and controls for complaints related to clinical events were identified.Based on review of the information available, urinary retention and hematoma are known risk associated with the use of the device and is noted as such in the instruction for use (ifu).An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.
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Event Description
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It was reported that six days post a convective radiofrequency water vapor thermal therapy procedure of the prostate, the patient had a heart attack.It is unsure what the symptoms were but it was noted that the patient was straining to urinate and had bowel movement.The patient received a cardiac stent, anticoagulation therapy, and surgery for a suprapubic catheter due to a blood clot in the bladder.The patient was in and out of icu over the last 3 weeks and reported to have had surgery again (unknown cause) at 21 days post the index procedure.No further information is available.
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Search Alerts/Recalls
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