MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number D2201

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Micturition Urgency (1871); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Chills (2191); Urinary Frequency (2275); Sweating (2444); Diaphoresis (2452)

Event Date 10/01/2020

Event Type  Injury  

Event Description

It was reported that this patient underwent carotid surgery on (b)(6) 2019.After surgery, the patient could not urinate.The hospital staff notified the on-call urologist of the situation; however, the urologist was unable to see the patient and recommended sending the patient home with foley catheter to help drain their bladder.On (b)(6) 2019, the patient had an appointment with their urologist, who verified the patient had an enlarged prostate and recommended a rezum procedure.The procedure took place on (b)(6) 2019.During this procedure, the physician reinserted a foley catheter and sent the patient home.On (b)(6) 2019, the patient presented to the urologist office with sweating and chills and was unable to pass urine via the foley catheter previously inserted.That same day, patient was admitted to hospital and treated with intravenous antibiotics for a urinary tract infection (uti).The patient was discharged from the hospital on (b)(6) 2019.Patient had a follow-up visit with their urologist to discuss the complication they experience, and the physician informed the patient there was nothing wrong and kept the foley catheter inserted.On (b)(6) 2019, the patient presented with sweating and chills again and notified the urologists office that he suspected another uti.The physician recommended self-catherization and provided the patient with the catheter kit.The physician also requested a urine sample; however, the sample was not analyzed (first time since consulting him).The patient was later scheduled to undergo a left carotid surgery and went to the hospital for pre-surgery testing.At the time of testing, the patient was experiencing urinary urgency, pain, and urinary frequency.The surgical staff informed the patient he had a uti and recommended contacting his urologist.The patient was seen by the urologist the day before the surgery was planned and inserted another foley catheter.On (b)(6) 2019, the left carotid surgery was performed with the foley catheter inserted.The next day, the patient was discharged from the hospital and decided to see a different urologist.The new physician suggested a cisto bladder stent procedure.After this procedure was completed, the patient has not experienced any further complications.Patient stated that the rezum procedure should not have been performed without first testing for uti.

Event Description

It was reported that this patient underwent carotid surgery on (b)(6) 2019.After surgery, the patient could not urinate.The hospital staff notified the on-call urologist of the situation; however, the urologist was unable to see the patient and recommended sending the patient home with foley catheter to help drain their bladder.On (b)(6) 2019, the patient had an appointment with their urologist, who verified the patient had an enlarged prostate and recommended a rezum procedure.The procedure took place on (b)(6) 20191.During this procedure, the physician reinserted a foley catheter and sent the patient home.On (b)(6) 2019, the patient presented to the urologist office with sweating and chills and was unable to pass urine via the foley catheter previously inserted.That same day, patient was admitted to hospital and treated with intravenous antibiotics for a urinary tract infection (uti).The patient was discharged from the hospital on (b)(6) 2019.Patient had a follow-up visit with their urologist to discuss the complication they experience, and the physician informed the patient there was nothing wrong and kept the foley catheter inserted.On (b)(6) 2019, the patient presented with sweating and chills again and notified the urologists office that he suspected another uti.The physician recommended self-catherization and provided the patient with the catheter kit.The physician also requested a urine sample; however, the sample was not analyzed (first time since consulting him).The patient was later scheduled to undergo a left carotid surgery and went to the hospital for pre-surgery testing.At the time of testing, the patient was experiencing urinary urgency, pain, and urinary frequency.The surgical staff informed the patient he had a uti and recommended contacting his urologist.The patient was seen by the urologist the day before the surgery was planned and inserted another foley catheter.On (b)(6) 2019, the left carotid surgery was performed with the foley catheter inserted.The next day, the patient was discharged from the hospital and decided to see a different urologist.The new physician suggested a cisto bladder stent procedure.After this procedure was completed, the patient has not experienced any further complications.Patient stated that the rezum procedure should not have been performed without first testing for uti.

Manufacturer Narrative

The device is not available for analysis.A review of the ifu and operators manual was completed and did not reveal any evidence of device misuse, off-label use, or failure to follow instructions.Based on review of the information available, urinary tract infection (with symptoms of urgency, frequency, pain, sweating and chills) and urinary retention are known risks associated with the use of the device and is noted as such in the instructions for use (ifu).An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

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.The reported patient symptoms are a known risk associated with rezum 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 urinary tract infection (with symptoms of urgency, frequency, pain, sweating and chills) and urinary retention were found to be listed in the ifu.Investigation conclusion: based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.

Event Description

It was reported that this patient underwent carotid surgery on (b)(6) 2019.After surgery, the patient could not urinate.The hospital staff notified the on-call urologist of the situation; however, the urologist was unable to see the patient and recommended sending the patient home with foley catheter to help drain their bladder.On (b)(6) 2019, the patient had an appointment with their urologist, who verified the patient had an enlarged prostate and recommended a rezum procedure.The procedure took place on (b)(6) 2019.During this procedure, the physician reinserted a foley catheter and sent the patient home.On (b)(6) 2019, the patient presented to the urologist office with sweating and chills and was unable to pass urine via the foley catheter previously inserted.That same day, patient was admitted to hospital and treated with intravenous antibiotics for a urinary tract infection (uti).The patient was discharged from the hospital on (b)(6) 2019.Patient had a follow-up visit with their urologist to discuss the complication they experience, and the physician informed the patient there was nothing wrong and kept the foley catheter inserted.On (b)(6) 2019, the patient presented with sweating and chills again and notified the urologist office that he suspected another uti.The physician recommended self-craterization and provided the patient with the catheter kit.The physician also requested a urine sample; however, the sample was not analyzed (first time since consulting him).The patient was later scheduled to undergo a left carotid surgery and went to the hospital for pre-surgery testing.At the time of testing, the patient was experiencing urinary urgency, pain, and urinary frequency.The surgical staff informed the patient he had a uti and recommended contacting his urologist.The patient was seen by the urologist the day before the surgery was planned and inserted another foley catheter.On (b)(6) 2019, the left carotid surgery was performed with the foley catheter inserted.The next day, the patient was discharged from the hospital and decided to see a different urologist.The new physician suggested a cisto bladder stent procedure.After this procedure was completed, the patient has not experienced any further complications.Patient stated that the rezum procedure should not have been performed without first testing for uti.The patient states he visited a new urologist to handle his concerns and take over his care.He ended up getting another procedure and is doing better now.

• Brand Name: REZUM
• Type of Device: UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10743627
• MDR Text Key: 213408036
• Report Number: 2937094-2020-00903
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention