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 Abscess (1690); Bacterial Infection (1735); Fever (1858); Inflammation (1932); Chills (2191)

Event Date 01/29/2020

Event Type  Injury  

Event Description

It was reported that the patient underwent water vapor thermal therapy procedure without problems.During medical exam at five ((b)(6) 2020) days post procedure there was a problem removing the probe installed during procedure from the patient bladder.The patient was put under corticoid treatment for 17 days to reduce the inflammation of the prostate.At 15 days ((b)(6) 2020), the patient was hospitalized again due to fever and chills.A urine test results revealed positive to morganelle morganii.Uroscanner and magnetic resonance imaging (mri) showed a prostatic abscess at the level of the area injected with the delivery device.The prostatic abscess was drained and surgical resection of the prostatic lobe was performed where the abscess was located.The patient was hospitalized for 10 days ((b)(6) 2020 through (b)(6) 2020) and was under antibiotic therapy for 26 days ((b)(6) 2020 through (b)(6) 2020).The patient current condition is unknown.

Manufacturer Narrative

The device is not available for analysis.A review of the device instructions for use (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, infection, is a known risk associated with the use of the device and is noted as such in the instruction for use (ifu).An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

Event Description

It was reported that the patient underwent water vapor thermal therapy procedure without problems.During medical exam at five ((b)(6) 2020) days post procedure there was a problem removing the probe installed during procedure from the patient bladder.The patient was put under corticoid treatment for 17 days to reduce the inflammation of the prostate.At 15 days ((b)(6) 2020), the patient was hospitalized again due to fever and chills.A urine test results revealed positive to morganelle morganii.Uroscanner and magnetic resonance imaging (mri) showed a prostatic abscess at the level of the area injected with the delivery device.The prostatic abscess was drained and surgical resection of the prostatic lobe was performed where the abscess was located.The patient was hospitalized for 10 days ((b)(6) 2020) and was under antibiotic therapy for 26 days ((b)(6) 2020).The patient current condition is unknown.

• 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: 10370813
• MDR Text Key: 201864833
• Report Number: 2937094-2020-00716
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/27/2020

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 Expiration Date: 06/30/2021
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 2019060926
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 08/19/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Weight: 75