BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
|
Back to Search Results |
|
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Inflammation (1932); Pain (1994); Urinary Retention (2119); Insufficient Information (4580)
|
Event Date 01/10/2022 |
Event Type
Injury
|
Event Description
|
It was reported that during a water vapor therapy procedure, a patient experienced intense pain during insertion of the delivery device and during delivery of treatment.The patient had been administered oral sedation.Five second into the procedure, the patient demanded the physician to stop the procedure.The patient hands shook for over an hour after the procedure was stopped.The procedure was cancelled, and the patient sent home.The patient returned later that day in retention.It was further noted that the delivery device was confirmed to be in good condition after unpacking and preparation.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, despite good faith efforts.
|
|
Event Description
|
It was reported that during a water vapor therapy procedure, a patient experienced intense pain during insertion of the delivery device and during delivery of treatment.The patient had been administered oral sedation.Five second into the procedure, the patient demanded the physician to stop the procedure.The patient hands shook for over an hour after the procedure was stopped.The procedure was cancelled and the patient was sent home.The patient returned later that day due to urinary retention caused by the inflammation from the procedure.It was further noted that the delivery device was confirmed to be in good condition after unpacking and preparation and that there was no delivery device performance issues during the procedure.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, or regarding any treatment for the patient urinary retention, despite good faith efforts.
|
|
Event Description
|
It was reported that during a water vapor therapy procedure, a patient experienced intense pain during insertion of the delivery device and during delivery of treatment.The patient had been administered oral sedation.Five second into the procedure, the patient demanded the physician to stop the procedure.The patient hands shook for over an hour after the procedure was stopped.The procedure was cancelled and the patient was sent home.The patient returned later that day due to urinary retention caused by the inflammation from the procedure.It was further noted that the delivery device was confirmed to be in good condition after unpacking and preparation and that there was no delivery device performance issues during the procedure.Boston scientific has been unable to obtain additional information regarding the patient outcome to date, or regarding any treatment for the patient urinary retention, despite good faith efforts.
|
|
Manufacturer Narrative
|
Investigation summary: based on the information available, there was no device available for analysis and there was no report of a device performance allegation during treatment.Boston scientific has been unable to obtain additional information regarding the hand shaking patient symptom, follow up treatments and patient current status to date, despite good faith efforts.The reported patient symptoms are known risks associated with water vapor therapy procedures and are noted as such in the device instructions for use.Device history record (dhr): a dhr and ship history review cannot be performed as the lot number was not available.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.Labeling review: the delivery device instructions for use (ifu) was reviewed.The patient symptoms of pain, urinary retention and inflammation were found to be listed in the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherit risk of device was assigned to this investigation.
|
|
Search Alerts/Recalls
|
|
|