MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION REZUM; UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

Model Number	D2201
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Codes	Hematoma (1884); Pain (1994)
Date of Event	05/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during a procedure with this device, the delivery device failed to retract completely.The delivery device was removed, but the patient was under duress and would not consent for the required additional treatment.It was noted that manual retraction was tried, however, the instructions to do it were unclear, causing at the end abrasion in the urethra as the device was retracted.The patient experienced a hematoma due to this and in addition the patient was instructed to drink additional water to clear the blood and to leave the catheter in placed until a follow up in 4 weeks.The procedure was aborted early, and the patient will need a second therapy.The patient is expected to fully recover.
Additional Manufacturer Narrative
Correction to field g1: mfr site country.Correction to field g1: mfr site zip/post code.Correction to field g1: mfr site state.Correction to field g1: mfr site city.Correction to field g1: mfr site address 2.Correction to field g1: mfr site address 1.Correction to field g1: mfr site facility name.The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Based on limited information available, a conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that, during a procedure with this device, the delivery device failed to retract completely.The delivery device was removed, but the patient was under duress and would not consent for the required additional treatment.It was noted that manual retraction was tried, however, the instructions to do it were unclear, causing at the end abrasion in the urethra as the device was retracted.The patient experienced a hematoma due to this and in addition the patient was instructed to drink additional water to clear the blood and to leave the catheter in placed until a follow up in 4 weeks.The procedure was aborted early, and the patient will need a second therapy.The patient is expected to fully recover.

• Brand Name: REZUM
• Common Device Name: UNIT, ELECTROSURGICAL ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; hakidma st 6; marlborough MA 01752
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19575317
• Report Number: 2124215-2024-35982
• Device Sequence Number: 18265906
• Product Code: KNS
• UDI-Device Identifier: 00855357006010
• UDI-Public: 00855357006010
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K180237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

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
• Operator of Device: Health Professional
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 07/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 72 KG