MAUDE Adverse Event Report: BTG YOKNEAM URETHRAL WARMING SET; UNIT, CRYOSURGICAL, ACCESSORIES

Model Number	FPRPR4003
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Urinary Retention (2119); Dysuria (2684)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Procry investigator-initiated clinical trial (prostate cancer foci targeted cryotherapy procry).It was reported that hospitalization was extended.A urethral warming set was selected for use in a cryoablation procedure.There was no problem with the device, and the procedure was completed.The next day, the balloon catheter was removed from the urethra and started to urinate, but residual urine was observed.Therefore, the patient's discharge from the hospital was extended for observation of urinary drainage due to postoperative dysuria.It was also suspected dysuria due to the side effect of the concomitant drug solifenacin succinate od tablets 5 mg (complication: overactive bladder), and discontinued the drug on the 9th.On the following two days, although residual urine persisted, dysuria and the patient's symptoms improved, and it was judged that the patient could be discharged from the hospital, and the patient was discharged.

• Brand Name: URETHRAL WARMING SET
• Common Device Name: UNIT, CRYOSURGICAL, ACCESSORIES
• Manufacturer (Section D): BTG YOKNEAM; tavor bldg 1, industrial park; po box 224; yokneam 20692 03; IS 2069203
• Manufacturer (Section G): GALIL ISRAEL; tavor bldg 1; yokneam 20692 03; IS 2069203
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15445274
• Report Number: 2124215-2022-35704
• Device Sequence Number: 18069724
• Product Code: GEH
• UDI-Device Identifier: 07290104830518
• UDI-Public: 07290104830518
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K010991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/14/2023
• Device Model Number: FPRPR4003
• Device Catalogue Number: FPRPR4003
• Device Lot Number: U3481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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: Hospitalization
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 61 KG