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 Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994); Complaint, Ill-Defined (2331)

Event Date 01/31/2020

Event Type  Injury  

Event Description

It was reported that this patient underwent convective radiofrequency water vapor thermal therapy procedure of the prostate on (b)(6) 2020 using the delivery device.Prior to the procedure the patients prostate specific antigen (psa) results and palpation of the prostate were not considered a concern.In (b)(6) 2020, the patient experienced heavy bleeding following sexual activity that lasted for 11 days as well as pain in the prostate area.In (b)(6) 2020, there was prostate inflammation.The patient is taking the prescribed medication but experienced tissue detachment at the end of (b)(6) 2020.The patients urinary stream is also weak and split.The urologist suspects there is residual tissue present and is considering performing a peeling procedure at a later date.No additional adverse patient effects were reported; however, the patients urinary stream is becoming weaker and the patient is concerned about prostate cancer.At this time, no further information on this event has been reported.

Manufacturer Narrative

The device is not available for analysis.A review of the ifu and operators manual was completed and did not reveal any evidence of device misuse, off-label use, or failure to follow instructions.Based on review of the information available, hemorrhage, pain and inflammation 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 the patient underwent convective radiofrequency water vapor thermal therapy procedure of the prostate on (b)(6) 2020, using the delivery device.Prior to the procedure the patient prostate specific antigen (psa) results and palpation of the prostate were not considered a concern.In (b)(6) 2020, the patient experienced heavy bleeding following sexual activity that lasted for 11 days as well as pain in the prostate area.In (b)(6) 2020, there was prostate inflammation.The patient is taking the prescribed medication but experienced tissue detachment at the end of (b)(6) 2020.The patient urinary stream is also weak and split.The urologist suspects there is residual tissue present and is considering performing a peeling procedure at a later date.No additional adverse patient effects were reported; however, the patient urinary stream is becoming weaker and the patient is concerned about prostate cancer.At this time, no further information on this event has been reported.

Event Description

It was reported that the patient underwent convective radiofrequency water vapor thermal therapy procedure of the prostate on (b)(6) 2020 using the delivery device.Prior to the procedure the patient's prostate specific antigen (psa) results and palpation of the prostate were not considered a concern.In (b)(6) 2020 the patient experienced heavy bleeding following sexual activity that lasted for 11 days as well as pain in the prostate area.In (b)(6) 2020 there was prostate inflammation.The patient is taking the prescribed medication but experienced tissue detachment at the end of (b)(6) 2020.The patients urinary stream is also weak and split.The urologist suspects there is residual tissue present and is considering performing a peeling procedure at a later date.No additional adverse patient effects were reported; however, the patient's urinary stream is becoming weaker and the patient is concerned about prostate cancer.At this time, no further information on this event has been reported.

Manufacturer Narrative

B1 adverse event/product problem field corrected.

• 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
• MDR Report Key: 10603970
• MDR Text Key: 209134342
• Report Number: 2937094-2020-00845
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 2019091037
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 10/15/2020; 12/15/2020
• Supplement Dates FDA Received: 11/05/2020; 12/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other