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 Incontinence (1928); Muscle Spasm(s) (1966); Urinary Tract Infection (2120)

Event Date 05/22/2019

Event Type  Injury  

Event Description

The patient was administered iv sedation, pain medication and general anesthesia.A total of 15 treatments were delivered.No adverse event occurred during the procedure.It was reported that at 2 days post convective radiofrequency water vapor thermal therapy procedure, the patient was experiencing intermittent bladder spasms.The patient described the pain as a cramping sensation in his lower abdomen extending into his penis.The patient self treated with ibuprofen 600mg.The patient was discharged with an indwelling catheter, which was removed 8 days post the index procedure.At 8 days post procedure, the patient was reported to be experiencing intermittent worsening of urge incontinence.There was no treatment administered for this symptom.At 14 days post the index procedure, the patient was reported to be experiencing an urinary tract infection (uti) for which urine culture tested positive.The patient was treated with 500mg of levaquin.The investigator assessment for the symptoms of worsening or urge incontinence, bladder spasms and uti were assessed as probable related to the procedure and device.

Manufacturer Narrative

The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.The device is not available for analysis.A review of the device 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 the information currently available, the patient symptoms are known risk associated with this type of procedure.An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

Event Description

The patient was administered iv sedation, pain medication and general anesthesia.A total of 15 treatments were delivered.No adverse event occurred during the procedure.It was reported that at 2 days post convective radiofrequency water vapor thermal therapy procedure, the patient was experiencing intermittent bladder spasms.The patient described the pain as a cramping sensation in his lower abdomen extending into his penis.The patient self treated with ibuprofen 600mg.The patient was discharged with an indwelling catheter, which was removed 8 days post the index procedure.At 8 days post procedure, the patient was reported to be experiencing intermittent worsening of urge incontinence.There was no treatment administered for this symptom.At 14 days post the index procedure, the patient was reported to be experiencing an urinary tract infection (uti) for which urine culture tested positive.The patient was treated with 500mg of levaquin.The patient uti was reported to have resolved 15 days post onset symptom.The investigator assessment for the symptoms of worsening or urge incontinence, bladder spasms and uti were assessed as probable related to the procedure and device.

Event Description

The patient was administered iv sedation, pain medication and general anesthesia.A total of 15 treatments were delivered.No adverse event occurred during the procedure.It was reported that at 2 days post convective radiofrequency water vapor thermal therapy procedure, the patient was experiencing intermittent bladder spasms.The patient described the pain as a cramping sensation in his lower abdomen extending into his penis.The patient self treated with ibuprofen 600mg.The patient was discharged with an indwelling catheter, which was removed 8 days post the index procedure.At 8 days post procedure, the patient was reported to be experiencing intermittent worsening of urge incontinence.There was no treatment administered for this symptom.At 14 days post the index procedure, the patient was reported to be experiencing an urinary tract infection (uti) for which urine culture tested positive.The patient was treated with 500mg of levaquin.The patient uti was reported to have resolved 15 days post onset symptom and the patient symptoms of bladder spasms and worsening of urge incontinence resolved approximately 6 months post onset symptoms.The investigator assessment for the symptoms of worsening or urge incontinence, bladder spasms and uti were assessed as probable related to the procedure and device.The clinical end committee (cec) adjudicated the event of worsening of urge incontinence as urinary incontinence and assessed the symptom as probable related to the treatment and possible related to the device.The bladder spasm, the cec adjudicated it as probable treatment related and unlikely related to the device.The patient was administered iv sedation, pain medication and general anesthesia.A total of 15 treatments were delivered.No adverse event occurred during the procedure.It was reported that at 2 days post convective radiofrequency water vapor thermal therapy procedure, the patient was experiencing intermittent bladder spasms.The patient described the pain as a cramping sensation in his lower abdomen extending into his penis.The patient self treated with ibuprofen 600mg.The patient was discharged with an indwelling catheter, which was removed 8 days post the index procedure.At 8 days post procedure, the patient was reported to be experiencing intermittent worsening of urge incontinence.There was no treatment administered for this symptom.At 14 days post the index procedure, the patient was reported to be experiencing an urinary tract infection (uti) for which urine culture tested positive.The patient was treated with 500mg of levaquin.The patient uti was reported to have resolved 15 days post onset symptom and the patient symptoms of bladder spasms and worsening of urge incontinence resolved approximately 6 months post onset symptoms.The investigator assessment for the symptoms of worsening or urge incontinence, bladder spasms and uti were assessed as probable related to the procedure and device.The clinical end committee (cec) adjudicated the event of worsening of urge incontinence as urinary incontinence and assessed the symptom as probable related to the treatment and possible related to the device.The bladder spasm, the cec adjudicated it as probable treatment related and unlikely related to the device.

Manufacturer Narrative

B5 event description: updated with worsening of urge incontinence and bladder spasm resolution and cec assessment.The device history record (dhr) confirmed that the devices met all material, assembly and performance specifications.The device is not available for analysis.A review of the device 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 the information currently available, the patient symptoms are known risk associated with this type of procedure.An evaluation conclusion code of known inherent risk of the device was assigned to this investigation.

• 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: 8769418
• MDR Text Key: 150384303
• Report Number: 2937094-2019-60839
• 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: study,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 06/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 2018101664
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 75 YR