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

Model Number D2201

Device Problems Retraction Problem (1536); Material Integrity Problem (2978)

Patient Problems Hemorrhage/Bleeding (1888); Device Overstimulation of Tissue (1991); Unspecified Tissue Injury (4559)

Event Date 11/02/2021

Event Type  Injury  

Event Description

It was reported that the patient was sedated in order to undergo a water vapor therapy procedure.The physician began the procedure by treating the left lateral lobe of the prostate with two treatments lasting nine second each without any difficulty.He then went on to treat the right lateral lobe and the first treatment was performed normally.After the second treatment which lasted nine seconds, the physician waited three seconds before retracting the needle.When he tried to retract the needle by pressing the retraction button, the needle did not retract.The device then began to administer another treatment into the right later lobe on its own without any action by the physician.To reduce the duration of this additional treatment which the physician did not intend, the physician attempted to quickly remove the barrel from the handpiece by removing the pin and manually retracting the needle.However, this did not work.The physician then gently removed the delivery device from the patient without the needle retracted while treatment was still being delivered.As a result, the final three seconds of treatment were delivered in the prostatic compartment.Additionally, because the needle had not been retracted when the device was removed, the needle caused a superficial lesion in the wall of the urethra which was accompanied with slight bleeding.The device then continued to deliver additional treatments outside the patient.A total of 16 treatments were completed by the device.The procedure was not completed due to the device issue.No additional treatment was required to treat the blood loss or urethral lesion.The physician has decided to observe the patient to see if there will be consequences from the overtreatment of the right lateral lobe, or from the diffusion of steam in the prostatic compartment.

Event Description

It was reported that the patient was sedated in order to undergo a water vapor therapy procedure.The physician began the procedure by treating the left lateral lobe of the prostate with two treatments lasting nine second each without any difficulty.He then went on to treat the right lateral lobe and the first treatment was performed normally.After the second treatment which lasted nine seconds, the physician waited three seconds before retracting the needle.When he tried to retract the needle by pressing the retraction button, the needle did not retract.The device then began to administer another treatment into the right later lobe on its own without any action by the physician.To reduce the duration of this additional treatment which the physician did not intend, the physician attempted to quickly remove the barrel from the handpiece by removing the pin and manually retracting the needle.However, this did not work.The physician then gently removed the delivery device from the patient without the needle retracted while treatment was still being delivered.As a result, the final three seconds of treatment were delivered in the prostatic compartment.Additionally, because the needle had not been retracted when the device was removed, the needle caused a superficial lesion in the wall of the urethra which was accompanied with slight bleeding.The device then continued to deliver additional treatments outside the patient.A total of 16 treatments were completed by the device.The procedure was not completed due to the device issue.It was noted that the amount of blood was low and only superficial.No additional treatment was required to treat the blood loss or urethral lesion.The physician has decided to observe the patient to see if there will be consequences from the overtreatment of the right lateral lobe, or from the diffusion of steam in the prostatic compartment.

Manufacturer Narrative

Investigation summary: with the available information boston scientific cannot conclusively establish the exact cause that contributed to the reported needle retraction difficulties during procedure.Functional testing was unable to replicate the reported needle retraction difficulties and inadvertent treatments despite the observed damages identified during analysis.It is unclear if the needle and needle sheath damage identified during analysis was a result of the reported event or handling after the procedure.Functional testing conducted confirmed functionality of all of the delivery device buttons.The generator responded whenever the needle retracted and deployed, flush, and vapor buttons were depressed and released.The reported needle retraction function difficulties could not be confirmed.Although a misaligned solenoid could cause the alleged retraction difficulties, it is unclear if this misalignment existed before the reported event, or if it was caused by the removal of the shaft and attempted manual needle retraction.Further analysis via x-ray and computer tomography imaging did not identify any additional abnormalities within the delivery device.In addition, analysis of the printed circuit board (pcb) did not identify any shorts or opens on any of the circuits of the pcb that could have cause or contributed to the reported needle retractions difficulties event and inadvertent additional treatments.A review of the device history record was performed confirming that the delivery device met material assembly and performance specification prior to release.Device history record (dhr) review: the device history record (dhr) confirmed that the device met all material, assembly and performance specifications.Device technical analysis: the delivery device was returned and upon receipt at our post market quality assurance laboratory, this device was thoroughly analyzed.Visual inspection confirmed that the delivery device was returned in a disassembled state.The delivery device shaft was completely removed.The delivery device needle and needle-sheath were damaged.It is unclear if this damage was a result of the reported event or handling after the procedure.The external housings were removed to visually inspect the interior of the delivery device.Interior inspection identified that the solenoid was out of alignment.It is possible for a misaligned solenoid to cause the alleged retraction difficulties, but it is unclear if this misalignment existed before the reported event, or if it was caused by the removal of the shaft and attempted manual needle retraction.Further analysis via x-ray and computer tomography imaging did not identify any additional abnormalities within the delivery device.Additional visual inspection of the printed circuit board (pcb) did not identify any shorts or opens on any of the circuits of the pcb.During functional evaluation, the delivery device was connected to a test generator.The testing conducted confirmed the functionality of all of the delivery device buttons.The generator responded whenever the retract, deploy, flush, and vapor buttons were depressed and released.Because of the disassembled state and the misaligned solenoid, further functional testing could not be performed.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off-label use, or that the guidance in the ifu was not followed.Investigation conclusion: based on analysis results and information currently available, the exact cause that contributed to the needle retractions difficulties and inadvertent treatment could not be established.Therefore, a conclusion code of cause not established was assigned to this investigation.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: alyson harris ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 4089353452
• MDR Report Key: 12782973
• MDR Text Key: 280571872
• Report Number: 2124215-2021-34637
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2023
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 0026961319
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2021
• 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
• Treatment: MODEL: G2200-0031SERIAL: (B)(6) ; MODEL: G2200-0031SERIAL: (B)(6)
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male