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

Model Number	M0061603350
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a percuflex urinary diversion stent was used during a procedure performed on september 25, 2023.During the procedure, the stent was damaged.It was noted that the pigtail part was torn.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.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable investigation results of the stent detached/separated.Block h10: the returned percuflex urinary diversion stent was analyzed, and a visual and microscopic evaluation noted that the coil shaft detached.No other problems with the device were noted.The reported event of stent torn material was not confirmed.Taking all available information into consideration, most likely, it 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 affected the device performance and its integrity.Therefore, the as analyzed code for this failure would be adverse event related to procedure.The reported problem of stent torn material was not confirmed since it was not detected during the analysis and for this reason, the as analyze code will be no problem detected.All compiled information on this investigation determines that cause not established is the most probable cause since the device complaint or problem cannot be confirmed at this point.

• Brand Name: PERCUFLEX URINARY DIVERSION STENT
• Common Device Name: 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: 18379515
• Report Number: 2124215-2023-71795
• Device Sequence Number: 7766926
• Product Code: LJE
• UDI-Device Identifier: 08714729821151
• UDI-Public: 08714729821151
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K830803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/21/2023

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
• Operator of Device: Health Professional
• Device Model Number: M0061603350
• Device Catalogue Number: 160-335
• Device Lot Number: 0031253345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 12/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown