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 Urinary Retention (2119); Dysuria (2684); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 01/14/2022

Event Type  Injury  

Event Description

It was reported by the patient that he underwent a water vapor therapy procedure. The device worked as intended during the procedure. The patient was catheterized until five days post procedure. The catheter was removed five days post procedure and the patient was not able to void himself. A catheter was reinserted and removed ten days post procedure. The patient still could not void himself and was instructed to self-catheterize. Thirteen days post procedure the patient was able to dribble a small amount of urine. The dribbling of small amount continued through sixteen days post procedure at which time he was able to produce a small stream, but not enough to empty his bladder. The flow had strengthened afterward, and the patient had not catheterized since sixteen days post procedure. The urine flow closed down at night, and the patient had to strain to produce very little urine. The patient had bad bladder spasms before and during urination and stinging during urination. The bladder spasms and the stinging had eased somewhat later.

Event Description

It was reported by the patient that he underwent a water vapor therapy procedure. The device worked as intended during the procedure. The patient was catheterized until five days post procedure. The catheter was removed five days post procedure and the patient was not able to void himself. A catheter was reinserted and removed ten days post procedure. The patient still could not void himself and was instructed to self-catheterize. Thirteen days post procedure the patient was able to dribble a small amount of urine. The dribbling of small amount continued through sixteen days post procedure at which time he was able to produce a small stream, but not enough to empty his bladder. The flow had strengthened afterward, and the patient had not catheterized since sixteen days post procedure. The urine flow closed down at night, and the patient had to strain to produce very little urine. The patient had bad bladder spasms before and during urination and stinging during urination. The bladder spasms and the stinging had eased somewhat later.

• 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: 13563928
• MDR Text Key: 285984146
• Report Number: 2124215-2022-05146
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191505
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: D2201
• Device Catalogue Number: D2201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2022
• 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 Treatment Data

Date Received: 02/18/2022 Patient Sequence Number: 1