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

Model Number M0061603300

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 01/09/2024

Event Type  malfunction  

Manufacturer Narrative

H6: imdrf device code a0401 captures the reportable investigation results of stent detached/separated.H10: the returned percuflex urinary diversion stent was analyzed, and a visual and microscopic evaluation noted that the coil was kinked and cut at the shaft.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 probable that the problem was caused due to the interaction between the guidewire and the stent device as well, such as the handling of the device could have contributed with the complaint event reported.Regarding founded issue of stent shaft detached, based on the irregular shape of the detached tip, there is enough evidence to conclude that the device was cut.Therefore, all compiled information on this investigation determines that the most probable cause is unintended use error cause or contributed to event since the interaction between the user and device, or sample, caused or contributed to the error.

Event Description

It was reported to boston scientific corporation that a percuflex urinary diversion stent was used during a procedure performed on (b)(6) 2024.During preparation, the stent was damaged.It was found that the pigtail part was kinked.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: 19000475
• MDR Text Key: 338901135
• Report Number: 2124215-2024-17768
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 08714729821144
• UDI-Public: 08714729821144
• 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: M0061603300
• Device Catalogue Number: 160-330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• 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