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 Unspecified Infection (1930); Necrosis (1971); Hematuria (2558)

Event Date 01/12/2022

Event Type  Injury  

Event Description

It was reported that the patient had a water vapor therapy procedure to treat his benign prostatic hyperplasia.The patient's prostate was larger than 50 grams, a large medium lobe and an inflatable penile prosthesis grade three.The patient stopped antiplatelet medication seven days prior to the procedure and resumed aspirin and plavix medication three days post procedure.The patient had a total of six treatments with the device.The patient also had an inflatable penile prosthesis(ipp) implanted and during the procedure, the urologist decided to put cannabidiol(cbd) around the ipp for three weeks.The patient removed his cbd after three weeks post procedure and was doing well and able to urinate after removing the cbd.Days later, the patient was admitted to the hospital due to excessive bleeding.The cystoscopy showed that the patient's prostate had shrunk, however, a massive necrotic tissue was over the prostate including the median and lateral lobe which caused the patient to bleed and the wound to be infected.The urologist used transurethral resection of the prostate (turp) to resect the necrotic tissue.The patient was discharged and the patient condition following the procedure was stable.There is no allegation on the device or the utilization of the device.

Event Description

It was reported that the patient had a water vapor therapy procedure to treat his benign prostatic hyperplasia.The patient's prostate was larger than 50 grams, a large medium lobe and an inflatable penile prosthesis grade three.The patient stopped antiplatelet medication seven days prior to the procedure and resumed aspirin and plavix medication three days post procedure.The patient had a total of six treatments with the device.The patient also had an inflatable penile prosthesis(ipp) implanted and during the procedure, the urologist decided to put cbd around the ipp for three weeks.The patient removed his cbd after three weeks post procedure and was doing well and able to urinate after removing the cbd.Days later, the patient was admitted to the hospital due to excessive bleeding.The cystoscopy showed that the patient's prostate had shrunk, however, a massive necrotic tissue was over the prostate including the median and lateral lobe which caused the patient to bleed and the wound to be infected.The urologist used transurethral resection of the prostate (turp) to resect the necrotic tissue.The patient was discharged and the patient condition following the procedure was stable.There is no allegation on the device or the utilization of the device.

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 known risk associated with a water vapor therapy procedure 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 and facility account number were 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 hematuria and infection 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.

• 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: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 13588754
• MDR Text Key: 286050667
• Report Number: 2124215-2022-05449
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2023
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 0028081372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 02/24/2022
• Supplement Dates FDA Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• 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
• Patient Age: 63 YR
• Patient Sex: Male