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

Model Number D2201

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Necrosis (1971); Dysuria (2684); Swelling/ Edema (4577)

Event Date 03/04/2020

Event Type  Injury  

Manufacturer Narrative

(initial report phone): (b)(6).

Event Description

Boston scientific corporation (bsc) became aware of an article published in the cereus journal of medical science.The article detailed the case of a 50 year old male who presented complaining of frequency, nocturia, hesitancy, weak stream, and post micturition dribbling.The patient was prescribed tamsulosin, then dutasteride but with no improvement.The patient's uroflowmetry peak flow was 11 milliliters per second (ml/s), qmax was 14 ml/s, post-void residual urine was 70 ml, prostate-specific antigen was 0.68 nanograms per milliliter (ng/ml) and his prostate volume was 34.7 milliliters.The patient was offered rezum water vapor therapy technique.Following the procedure, a size 18 foley catheter was placed.Four days post procedure, the size 18 foley catheter was removed, and the patient voided freely.The patient was seen in the clinic two weeks post procedure and was complaining of severe dysuria and weak stream.Urinalysis and culture were both were negative.The patient's symptoms were relieved mildly with analgesics.The patient had a further follow-up at the clinic three weeks later, where he was scoped and extensive sloughed tissue was found in the prostatic urethra.The doctor determined the patient's symptoms were due to edema and inflammation.50 days post the index procedure, the patient underwent a transurethral resection of the prostate (turp) procedure, and the necrotic tissue was removed by resectoscope and electrocautery (fulguration) was used for hemostasis.One day following the surgery the foley catheter was removed and the patient was discharged.Two weeks after catheter removal, the patient was seen in a follow-up appointment at which time the symptoms were relieved.A boston scientific representative was present in this case and observed that the cystoscopic examination identified that the patient's prostate needed 7 treatment cycles with rezum.However, during the procedure, the doctor administered 13 treatment cycles despite instructions from the manufacturer's representatives stating the patient was being over-treated.

Manufacturer Narrative

Additional information provided in: d3 (manufacturer fax), and d4 (lot number, expiration date, and unique identifier).Investigation summary: boston scientific's analysis of all available information concludes that the rezum delivery device instructions for use (ifu) were not followed during the patient treatment, likely contributing to the reported patient event.Based on a thorough review of the literature article, there was no rezum delivery device performance issue encountered during the procedure that could have caused or contributed to the patient symptoms, and the delivery device history record confirmed that the delivery device met specifications prior to release.According to the rezum delivery device ifu, the recommended number of treatments per lobe is 3-4 treatments per lobe if the distance from the bladder neck to the verumontanum is greater than 3.0 cm.Per the literature article, the patient s prostate measured 3.47 cm.The boston scientific representative present at the referenced case communicated to the physician that the cystoscopy exam identified that the prostate needed a total of seven (7) treatment cycles; however, 13 treatment cycles were administered by the physician despite the boston scientific representative informing the physician that the patient was being overtreated.The rezum delivery device ifu provides the following precaution: excessive treatments: treatments in excess of those recommended in the guidelines may lead to prolonged irritative symptoms and/or catheterization.As a result of all the additional information provided by the boston scientific representative at the case, the physician was retrained on the safe and effective utilization of the rezum system for benign prostatic hyperplasia (bph) treatment.Device history record (dhr) review: the device history record (dhr) confirmed that the device met all material, assembly, and performance specifications.Device technical analysis: to date, the rezum delivery device has not been returned for analysis.Therefore, no physical or visual analysis of the delivery device could be performed.Labeling review: a review of the rezum delivery device ifu was performed.The device s ifu lists dysuria, and necrosis (cell death) as potential adverse events associated with use of the referenced device.Also, the ifu provides the following guidelines for estimating the number of treatments: estimate the prostatic treatment (i.E.From bladder neck to verumontanum).This length is considered the vapor treatment zone.Based on the length of the vapor treatment zone, determine the number of treatments per lobe.A treatment consists of a single 9-second delivery of vapor.In addition, the ifu (table 2) provides guidelines for determine the number of treatments in the lateral lobes, indicating if the distance from the bladder neck to the verumontanum is 3.0 cm, 3 to 4 treatments per lobe are estimated.The ifu also provides the following guidance for median lobe treatment: if a median lobe is present and judged to be in need of treatment, deliver one treatment if median lobe is 2 cm and two or more treatments if median lobe is 2 cm.The ifu also indicates the following precaution: excessive treatments: treatments in excess of those recommended in the guidelines may lead to prolonged irritative symptoms and/or catheterization.Risk review: a review of the rezum delivery device hazard analysis (ha) was completed and confirmed that the events of overtreatment/unintended tissue being treated, dysuria, necrosis, and inflammation were defined in the risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on the available information, bsc s investigation did not confirm a device problem.The rezum delivery device met all design and manufacturing specifications prior to distribution.Bsc assigned the referenced event the investigation conclusion code of failure to follow instructions, because the event was traced to the user not following the manufacturer s instructions, subsequently overtreating the prostate.

Event Description

Boston scientific corporation (bsc) became aware of an article published in the cereus journal of medical science.The article detailed the case of a 50 year old male with known comorbidities of diabetes mellitus, hypertension, dyslipidemia, and benign prostatic hyperplasia (bph).The patient presented complaining of frequency, nocturia, hesitancy, weak stream, and post micturition dribbling.The patient was prescribed tamsulosin, then dutasteride but with no improvement.The patient's uroflowmetry peak flow was 11 milliliters per second (ml/s), qmax was 14 ml/s, post-void residual urine was 70 ml, prostate-specific antigen was 0.68 nanograms per milliliter (ng/ml) and his prostate volume was 34.7 milliliters.The patient was offered rezum water vapor therapy technique.Following the procedure, a size 18 foley catheter was placed.Four days post procedure, the size 18 foley catheter was removed, and the patient voided freely.The patient was seen in the clinic two weeks post procedure and was complaining of severe dysuria and weak stream.Urinalysis and culture were both were negative.The patient's symptoms were relieved mildly with analgesics.The patient had a further follow-up at the clinic three weeks later, where he was scoped and extensive sloughed tissue was found in the prostatic urethra.The doctor determined the patient's symptoms were due to edema and inflammation.50 days post the index procedure, the patient underwent a transurethral resection of the prostate (turp) procedure, and the necrotic tissue was removed by resectoscope and electrocautery (fulguration) was used for hemostasis.One day following the surgery the foley catheter was removed and the patient was discharged.Two weeks after catheter removal, the patient was seen in a follow-up appointment at which time the symptoms were relieved.A boston scientific representative was present in this case and observed that the cystoscopic examination identified that the patient's prostate needed 7 treatment cycles with rezum.However, during the procedure, the doctor administered 13 treatment cycles despite instructions from the manufacturer's representatives stating the patient was being over-treated.

• 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: 11477050
• MDR Text Key: 239702729
• Report Number: 2937094-2021-00235
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: D2201
• Device Catalogue Number: D2201
• Device Lot Number: 2019090664
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR