MAUDE Adverse Event Report: MEDPLAST MEDICAL, INC. REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number D2201

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Thrombosis (2100); Urinary Retention (2119); Complaint, Ill-Defined (2331)

Event Date 04/29/2019

Event Type  Injury  

Event Description

It was reported that six days post a convective radiofrequency water vapor thermal therapy procedure of the prostate, the patient had a heart attack.It is unsure what the symptoms were but it was noted that the patient was straining to urinate and had bowel movement.The patient received a cardiac stent, anticoagulation therapy, and surgery for a suprapubic catheter due to a blood clot in the bladder.The patient was in and out of icu over the last 3 weeks and reported to have had surgery again (unknown cause) at 21 days post the index procedure.No further information is available.

Event Description

It was reported that six days post a convective radiofrequency water vapor thermal therapy procedure of the prostate, the patient had a heart attack.It is unsure what the symptoms were but it was noted that the patient was straining to urinate and had bowel movement.The patient received a cardiac stent, anticoagulation therapy, and surgery for a suprapubic catheter due to a blood clot in the bladder.The patient was in and out of icu over the last 3 weeks and reported to have had surgery again (unknown cause) at 21 days post the index procedure.No further information is available.

Manufacturer Narrative

Patient code corrected from thrombosis 2100 to hematoma 1884.

Manufacturer Narrative

The device is not available for analysis.A review of the rezum ifu and operators manual was completed and did not reveal any evidence of device misuse, off-label use, or failure to follow instructions.The potential cause and controls for complaints related to clinical events were identified.Based on review of the information available, urinary retention and hematoma are 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 six days post a convective radiofrequency water vapor thermal therapy procedure of the prostate, the patient had a heart attack.It is unsure what the symptoms were but it was noted that the patient was straining to urinate and had bowel movement.The patient received a cardiac stent, anticoagulation therapy, and surgery for a suprapubic catheter due to a blood clot in the bladder.The patient was in and out of icu over the last 3 weeks and reported to have had surgery again (unknown cause) at 21 days post the index procedure.No further information is available.

• Brand Name: REZUM
• Type of Device: UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): MEDPLAST MEDICAL, INC.; 5079 33rd street se; grand rapids MI 49512
• MDR Report Key: 8685464
• MDR Text Key: 147566512
• Report Number: 2937094-2019-60689
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2019

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: 05/13/2019
• Initial Date FDA Received: 06/10/2019
• Supplement Dates Manufacturer Received: 05/13/2019; 07/09/2019
• Supplement Dates FDA Received: 06/11/2019; 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1