MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX PLUS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M0061752520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a ureteroscopy procedure performed on (b)(6) 2023.During preparation, it was noted that the catheter was found broken when opening the secondary packaging of the device.The procedure was successfully completed.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.Block h10: the returned percuflex plus ureteral stent was analyzed, and a visual and microscopic evaluation noted that the bladder coil was detached, and suture hole was torn until the tip.Additionally, their suture was returned removed indicating that the device was used.No other problems with the device were noted.The reported event was not 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.These problems could have been cause due to an interaction of the device with the suture string such as entanglement, manipulation or excess of force applied over the device during the setting up.The retrieval line may be cut prior to stent placement.Remove the retrieval line by holding the knot, cutting one strand, and while holding the knot, gently pull out the retrieval line.In this reason, the as analyzed cause code will be failure to follow instructions.For the reported problem of stent shaft break was not confirmed since the break was not detected during the analysis.Therefore, the as analyze code will be no problem detected.All compiled information on this investigation determines that the most probable cause is failure to follow instructions since problems traced to the user not following the manufacturer's instructions.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a ureteroscopy procedure performed on (b)(6) 2023.During preparation, it was noted that the catheter was found broken when opening the secondary packaging of the device.The procedure was successfully completed.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: PERCUFLEX PLUS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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 ; 5086834015
• MDR Report Key: 18127519
• Report Number: 2124215-2023-61976
• Device Sequence Number: 18071208
• Product Code: FAD
• UDI-Device Identifier: 08714729056805
• UDI-Public: 08714729056805
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K924608
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2026
• Device Model Number: M0061752520
• Device Catalogue Number: 175-252
• Device Lot Number: 0030921650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/19/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 01/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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