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 Dehydration (1807); Impotence (1925); Incontinence (1928); Unspecified Infection (1930); Weakness (2145); Patient Problem/Medical Problem (2688)

Event Date 01/22/2020

Event Type  Injury  

Event Description

It was reported that three days post a convective radiofrequency water vapor thermal therapy procedure the patient went to the emergency room due to his blood pressure being 70/54. The patient was dehydrated and weak. Once the patient was stabilized it was discovered, that the patients creatinine level was 9. 8. The patient was admitted and hospitalized for six days. Per the patient, the physician is convinced that the kidney issues were a result of the procedure. The physician decided to observe the patient and release him when creatinine level reached 7. 2. The patient is still being monitored and the last blood test revealed that a 2. 9 creatinine level, which is still high, but manageable. The patient has also stated that his urine flow was good for a while, but it is now inconsistent. The urine flow is okay during the day but weaker at night, wake up every 2 hours to urinate, feels the urge to urinate, and many times barely makes it to the toilet before leaking urine. The patient has not been able to have an erection since the procedure. His urologist recommended cialis.

• 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 ; 150 baytech drive; san jose, CA 95134 ; 4089353452
• MDR Report Key: 10399129
• MDR Text Key: 202696122
• Report Number: 2937094-2020-00710
• 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: consumer
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• 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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/20/2020
• 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: 08/12/2020 Patient Sequence Number: 1