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 Stroke/CVA (1770); Death (1802); Myocardial Infarction (1969); Pain (1994)

Event Date 09/13/2019

Event Type  Death  

Event Description

It was reported that a registered nurse, reporting on behalf of her father, called to report that he has had three myocardial infarctions and one stroke the following day of having a benign prostate hyperplasia procedure with the use of rezum.Reporter states that her father told her after the procedure that it was extremely painful and would not have done this type of procedure if he had known that it was as painful as it was.Also, this type of procedure was recormmended by his doctor because of his history of heart disease.My father had to start hospice on (b6) 2019 and he died on (b)(6) 2019.Event outcome: death((b)(4)), hospitalization.

Manufacturer Narrative

The product was not returned to the manufacturer.A risk and labeling review was performed.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.A review of the rezum system hazard analysis was completed and the potential cause(s) and controls for complaints related to the clinical event were identified.Based on review of this data, the patient symptom of pain does not represent a new or unanticipated event.There is insufficient information to determine if the cause of the patient myocardial infarction, cerebral vascular accident and death was associated with the rezum device and/or procedure.Based on the information available a conclusion code of no problem detected was assigned to this investigation.

Event Description

It was reported that a registered nurse, reporting on behalf of her father, called to report that he has had three myocardial infarctions and one stroke the following day of having a benign prostate hyperplasia procedure with the use of rezum.Reporter states that her father told her after the procedure that it was extremely painful and would not have done this type of procedure if he had known that it was as painful as it was.Also, this type of procedure was recormmended by his doctor because of his history of heart disease.My father had to start hospice on (b6)(6) 2019 and he died on (b)(6) 2019.Event outcome: death((b)(4)), hospitalization.

• Brand Name: REZUM
• Type of Device: UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• MDR Report Key: 9512771
• MDR Text Key: 172553351
• Report Number: 3001236349-2019-00004
• 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,other
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• 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
• Date Manufacturer Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death