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 Sepsis (2067); Urinary Tract Infection (2120)

Event Date 01/01/2021

Event Type  Injury  

Event Description

It was reported that following a successful water vapor therapy procedure, the physician found an intraprostatic urinoma which led to an urinary tract infection (uti).The infection then progressed to sepsis.The physician believes the intraprostatic urinoma was created by leaving tissue adjacent to the prostatic urethra untouched while removing other tissue.The cavity in the prostate eventually filled with urine and became infected.The physician performed a transurethral resection of the prostate (turp) to remove the intraprostatic urinoma, and the patient was reported to have made full recovery.

Event Description

It was reported that following a successful water vapor therapy procedure, the physician found an intraprostatic urinoma which led to an urinary tract infection (uti).The infection then progressed to sepsis.The physician believes the intraprostatic urinoma was created by leaving tissue adjacent to the prostatic urethra untouched while removing other tissue.The cavity in the prostate eventually filled with urine and became infected.The physician performed a transurethral resection of the prostate (turp) to remove the intraprostatic urinoma, and the patient was reported to have made full recovery.

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 urinary tract infection (uti) and sepsis 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
• MDR Report Key: 11596014
• MDR Text Key: 243749081
• Report Number: 2937094-2021-00281
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

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: D2201
• Device Catalogue Number: D2201
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/04/2021
• Initial Date FDA Received: 03/31/2021
• Supplement Dates Manufacturer Received: 04/08/2021
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention