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 Urinary Retention (2119); Blood Loss (2597); No Code Available (3191)

Event Date 03/05/2019

Event Type  Injury  

Event Description

It was reported that convective radiofrequency water vapor thermal therapy with rezum product was completed successfully with no clinical consequences to the patient.However, the patient went into urinary retention same day, post procedure, and went to the emergency room for catheter placement.Five days after catheter placement the patient was seen for catheter removal and patient passed void trial, however later the same day the patient was in retention and was admitted to urgent care.Patient was seen the next day for catheter removal and taught how to catheterize himself.Patient self catheterized for 9-14 days more day with improved retention however then the patient developed bleeding and was advised to minimize catheterizing.Patient continued to exhibit episodes of urinary retention and bleeding.The physician performed a cystoscopy in the office (placement of scope into the bladder to look for source of urine retention or bleeding) and found the prostate to appear "normal for just being vaporized".There was minimal amount of ooze at the bladder neck and no active bleeding noticed.Patient prescribed myrbetriq (medication used to treat overactive bladder).Bleeding and catheterization had stopped, however during a return flight from a business trip, from (b)(6), the patient exhibited severe bleeding, clot and urinary retention and the plane was diverted to (b)(6).Patient was taken to the hospital where "he" a catheter was placed and irrigated.A bleeder was found and the bleeder was cauterized to stop the bleeding.Patient's catheter was removed the next day with no observed bleeding however the following day bleeding reoccurred.The patient was readmitted and debating treatment options of cauterization or transurethral resection of the prostate (turp).The patient has not returned to the physician.The physician believes that the patient's symptoms are related the rezum treatment.Patient's current condition is unknown.

• 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
• Manufacturer (Section G): MEDPLAST MEDICAL, INC.; 5079 33rd street se; grand rapids MI 49512
• Manufacturer Contact: alyson harris ; 150 baytech drive; san jose, CA 95134 ; 4089353452
• MDR Report Key: 8462575
• MDR Text Key: 140336101
• Report Number: 2937094-2019-60421
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180237
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2019
• 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 Sequence Number: 1
• Patient Outcome(s): Other