MAUDE Adverse Event Report: UROTRONIC, INC. OPTILUME URETHRAL DRUG COATED BALLOON

Model Number 1110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/16/2022

Event Type  Injury  

Manufacturer Narrative

An attempt to retrieve the product was unsuccessful and the customer discarded the product.Currently it is unknown whether or not the device may have caused or contributed to the event, as the product has not been returned.Urotronic through it's distributor has made reasonable efforts to obtain more complete information in the time allotted to report and has provided all available information at the time of submission of this report.Any required fields that are blank are due to information that is currently unknown or unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Patient has multi-focal stricture(s) of the penile and bulbar urethra with multiple prior dilations, etiology likely iatrogenic from multiple foley placements and prior instrumentations.Was not considered a good candidate for urethroplasty given total length of reconstruction required so decided to utilize optilume.Medical history includes leukemia with radiation of retroperitoneal lymph nodes and testicular cancer with bilateral orchiectomy.On the day of treatment, proximal strictures were not flow limiting and allowed passage of the scope to the level of the bulbar urethra.Dense/fibrotic bulbar stricture did not allow passage of the scope, was pre-dilated.Scope was able to pass to bladder after pre-dilation.A single 30f x 50mm optilume urethral dcb was advanced into position across the bulbar stricture and inflated for 5 minutes.A foley catheter was placed.Patient returned 3 days post-op for foley removal, was observed to be in good health.At 10 days post-op, the subject returns with complaints of urine leakage from the penile shaft near the base of the penis, diagnosis of a urethrocutaneous fistula noted.Physician encountered difficulty advancing a ureteroscope through the meatus and proximal urethra due to obstruction, but was eventually able to access the bladder.A suprapubic catheter was placed.Patient returns 4 weeks post-op and a retrograde urethrogram was conducted.Imaging noted an obliterative stricture in the proximal penile urethra, urethrocutaneous fistula was noted as qualitatively resolved.

Manufacturer Narrative

Available event information was reviewed by a qualified physician who concludes that the device is unlikely the direct cause of the adverse event, but contribution of the device to the event cannot be ruled out.

• Brand Name: OPTILUME URETHRAL DRUG COATED BALLOON
• Type of Device: URETHRAL DRUG COATED BALLOON
• Manufacturer (Section D): UROTRONIC, INC.; 2495 xenium lane north; minneapolis MN 55441
• Manufacturer (Section G): UROTRONIC, INC.; 2495 xenium lane north; minneapolis MN 55441
• Manufacturer Contact: alex zuniga ; 2495 xenium lane north; minneapolis, MN 55441 ; 7632857496
• MDR Report Key: 16244896
• MDR Text Key: 308144001
• Report Number: 3015228875-2023-00001
• Device Sequence Number: 1
• Product Code: QRH
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P210020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1110
• Device Catalogue Number: 1110 10050B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male