MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX URINARY DIVERSION STENT; CATHETER, NEPHROSTOMY

Model Number M0061603250

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2023

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable investigation results of stent detached/separated.Block h10: the returned percuflex urinary diversion stent was analyzed, and a visual and microscopic evaluation noted that the shaft was detached with remains of an unknown glue over the device, torn along the shaft, and in the detached sides.The detached sides look stretched and one of the detached sides looks like it has been cut.No other problems with the device were noted.The reported event was confirmed.Taking all available information into consideration, most likely, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.It is possible that some type of adessive synth was placed in the device to be fixed and stabilized, the detachment observed in both ends of shafts may be due to the state of the device that was stretched and tensioned until its separation.One ends of one of the devices was cut with an unknown tool.The returned devices show a lot of manipulation the torn founded along the device may be related with some other factors such as excessive handling of the device, the technique used by the physician and normal procedural difficulties encountered during the procedure.Therefore, all compiled information on this investigation determines that the most probable cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on event.

Event Description

Note: this report is one of two complaints that pertain to the same event (mfr report # mfr.Report # 2124215-2024-17757).It was reported to boston scientific corporation that a percuflex urinary diversion stent was successfully implanted during a procedure.The event date was not reported.During a routine follow-up, the two implanted stents from left and right anatomy were found torn at the part protruding outside the patient.The procedure was successfully completed with another percuflex urinary diversion stent.There were no patient complications reported as a result of this event.Investigation results revealed that the stent was detached/separated, therefore this event has been deemed an mdr reportable event.Please see block h10 for full investigation details.

• Brand Name: PERCUFLEX URINARY DIVERSION STENT
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19000726
• MDR Text Key: 339146690
• Report Number: 2124215-2024-17751
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 08714729821137
• UDI-Public: 08714729821137
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K830803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0061603250
• Device Catalogue Number: 160-325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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