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

Model Number M0061603250

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 01/01/2024

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a percuflex urinary diversion stent was used during a procedure.The event date was not reported.During the procedure, the stent was found damaged.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.

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 coil torn, and the shaft detached.No other problems with the device were noted.The reported event was confirmed.Taking all available information into consideration, most likely, the problem 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 that could have possibly affect the device performance and its integrity.The detachment found on the device shaft may be related to the interaction of the device with some unknown sharp tool.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.

• 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: 19000908
• MDR Text Key: 338983191
• Report Number: 2124215-2024-17488
• 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
• 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: 02/02/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/28/2024
• 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