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

Model Number UNK-D-PROSTATE HEALTH

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

Patient Problems Pain (1994); Urinary Retention (2119); Stenosis (2263); Ulcer (2274); Hematuria (2558); Dysuria (2684); Unspecified Mental, Emotional or Behavioural Problem (4430); Urinary Incontinence (4572); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/28/2021

Event Type  Injury  

Event Description

It was reported by a patient via social media that he underwent a prostate procedure and it was the most painful experience ever felt.The procedure gave the patient retrograde ejaculation and regretted having the procedure.

Manufacturer Narrative

Date of event the exact date of the event is unknown.

Event Description

It was reported by a patient via social media that he underwent a prostate procedure and it was the most painful experience he ever felt.He stated that the procedure caused retrograde ejaculation and that he regretted having it performed.No additional patient complications were reported.

Manufacturer Narrative

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 symptom of pain is a known risk associated with water vapor therapy procedures and is noted as such in the device instructions for use.Based on the information available, a conclusion code of known inherent risk of device use was assigned to this investigation.Correction: h6 patient codes - removed code that was redundant.B3.Date of event the exact date of the event is unknown.

Event Description

It was reported by a patient via social media that he underwent a prostate procedure and it was the most painful experience ever felt.The procedure gave the patient retrograde ejaculation and regretted having the procedure.

Manufacturer Narrative

Correction: h6 patient codes - removed code that was redundant.B3.Date of event: the exact date of the event is unknown.

Manufacturer Narrative

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 of pain, retrograde ejaculation, urinary retention, hematuria, and stenosis are known risks associated with water vapor therapy procedures and are noted as such in the device instructions for use.Based on the information available, a conclusion code of known inherent risk of device use was assigned to this investigation.

Event Description

It was reported by a patient via social media that he underwent a prostate procedure and it was the most painful experience ever felt.The procedure gave the patient retrograde ejaculation and regretted he having the procedure.The patient later contacted boston scientific via phone to provide additional details.He stated that on the day of the procedure, he was asked by the staff if he had taken his valium prescription.He told them that he had not received a prescription, and the staff proceeded with the procedure without any pain medication.He stated he experienced the worst pain he had ever experienced.After the procedure, he was instructed to try to urinate but he was unable to.After that, a catheter was placed.After the catheter had been in place for nine days, the patient started experiencing bleeding which was characterized by deep red blood in the catheter bag.He immediately contacted his urologist but was unable to get a hold of him.He called an ambulance and was then transferred to the hospital where he was given a sedative and instructed to see his urologist.Approximately two weeks after the water vapor therapy procedure, the patient underwent a hernia repair surgery.He spoke with the general surgeon regarding his pain and the surgeon referred him back to his urologist.The patient went back to his urologist and was placed on flomax.Approximately 4 weeks after the water vapor therapy procedure, the patient told his urologist he was unable to urinate and was instructed to come into the office.At some point in time the patient had undergone a cystoscope but the date it was performed was not provided.A second procedure was then done in order to make incisions to the bladder neck due to narrowing of the bladder neck.The patient believes the narrowing of the bladder neck was due to the water vapor therapy procedure and the catheter that was placed after he could not urinate for 4-6 days.He was also given pills that took his pain away and turned his pee orange for a few days.He then ended up at the hospital again due to pain while urinating which caused the patient to pull his sciatic nerve.The patient is currently using a heating pad for his pain as well as over-the-counter (otc) anti-inflammatory medication when needed.He reports he has suffered from stress ulcers, pain, and is seeing a therapist for the experience and pain he is in.

Manufacturer Narrative

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 symptom of pain is a known risk associated with water vapor therapy procedures and is noted as such in the device instructions for use.Based on the information available, a conclusion code of known inherent risk of device use was assigned to this investigation.

Event Description

It was reported by a patient via social media that he underwent a prostate procedure and it was the most painful experience ever felt.The procedure gave the patient retrograde ejaculation and he regretted having the procedure.

Manufacturer Narrative

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 symptom of pain is a known risk associated with water vapor therapy procedures and is noted as such in the device instructions for use.Based on the information available, a conclusion code of known inherent risk of device use was assigned to this investigation.

Event Description

It was reported by a patient via social media that he underwent a prostate procedure and it was the most painful experience ever felt.The procedure gave the patient retrograde ejaculation and regretted he having the procedure.The patient later contacted boston scientific via phone to provide additional details.He stated that on the day of the procedure, he was asked by the staff if he had taken his valium prescription.He told them that he had not received a prescription, and the staff proceeded with the procedure without any pain medication.He stated he experienced the worst pain he had ever experienced.After the procedure, he was instructed to try to urinate but he was unable to.After that, a catheter was placed.After the catheter had been in place for nine days, the patient started experiencing bleeding which was characterized by deep red blood in the catheter bag.He immediately contacted his urologist but was unable to get a hold of him.He called an ambulance and was then transferred to the hospital where he was given a sedative and instructed to see his urologist.Approximately two weeks after the water vapor therapy procedure, the patient underwent a hernia repair surgery.He spoke with the general surgeon regarding his pain and the surgeon referred him back to his urologist.The patient went back to his urologist and was placed on flomax.Approximately 4 weeks after the water vapor therapy procedure, the patient told his urologist he was unable to urinate and was instructed to come into the office.At some point in time the patient had undergone a cystoscope but the date it was performed was not provided.A second procedure was then done in order to make incisions to the bladder neck due to narrowing of the bladder neck.The patient believes the narrowing of the bladder neck was due to the water vapor therapy procedure and the catheter that was placed after he could not urinate for 4-6 days.He was also given pills that took his pain away and turned his pee orange for a few days.He then ended up at the hospital again due to pain while urinating which caused the patient to pull his sciatic nerve.The patient is currently using a heating pad for his pain as well as over-the-counter (otc) anti-inflammatory medication when needed.He reports he has suffered from stress ulcers, pain, and is seeing a therapist for the experience and pain he is in.

Manufacturer Narrative

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 of pain, retrograde ejaculation, urinary retention, hematuria, and stenosis are known risks associated with water vapor therapy procedures and are noted as such in the device instructions for use.Based on the information available, a conclusion code of known inherent risk of device use was assigned to this investigation.

Event Description

It was reported by a patient via social media that he underwent a prostate procedure and it was the most painful experience ever felt.The procedure gave the patient retrograde ejaculation and regretted he having the procedure.The patient later contacted boston scientific via phone to provide additional details.He stated that on the day of the procedure, he was asked by the staff if he had taken his valium prescription.He told them that he had not received a prescription, and the staff proceeded with the procedure without any pain medication.He stated he experienced the worst pain he had ever experienced.After the procedure, he was instructed to try to urinate but he was unable to.After that, a catheter was placed.After the catheter had been in place for nine days, the patient started experiencing bleeding which was characterized by deep red blood in the catheter bag.He immediately contacted his urologist but was unable to get a hold of him.He called an ambulance and was then transferred to the hospital where he was given a sedative and instructed to see his urologist.Approximately two weeks after the water vapor therapy procedure, the patient underwent a hernia repair surgery.He spoke with the general surgeon regarding his pain and the surgeon referred him back to his urologist.The patient went back to his urologist and was placed on flomax.Approximately 4 weeks after the water vapor therapy procedure, the patient told his urologist he was unable to urinate and was instructed to come into the office.At some point in time the patient had undergone a cystoscope but the date it was performed was not provided.A second procedure was then done in order to make incisions to the bladder neck due to narrowing of the bladder neck.The patient believes the narrowing of the bladder neck was due to the water vapor therapy procedure and the catheter that was placed after he could not urinate for 4-6 days.He was also given pills that took his pain away and turned his pee orange for a few days.He then ended up at the hospital again due to pain while urinating which caused the patient to pull his sciatic nerve.The patient is currently using a heating pad for his pain as well as over-the-counter (otc) anti-inflammatory medication when needed.He reports he has suffered from stress ulcers, pain, and is seeing a therapist for the experience and pain he is in.On (b)(6) 2024 the patient reported he is still frustrated and suffering from depression.He is experiencing pain when urinating and is also dripping urine.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 14522322
• MDR Text Key: 292807069
• Report Number: 2124215-2022-18255
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK-D-PROSTATE HEALTH
• Device Catalogue Number: UNK-D-PROSTATE HEALTH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2022
• Initial Date FDA Received: 05/27/2022
• Supplement Dates Manufacturer Received: 06/01/2022; 06/16/2022; 01/02/2023; 01/27/2023; 03/01/2023; 04/25/2024
• Supplement Dates FDA Received: 06/01/2022; 06/30/2022; 01/23/2023; 02/15/2023; 03/21/2023; 05/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other