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

Model Number	M0061453520
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920); Material Deformation (2976); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a0406 captures the reportable event of stent kinked, inside the patient.Imdrf device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that during insertion, resistance was felt at the front end of the stent, and folds were observed at the back end of the stent.The pigtail at the bladder end of the ureteral stent was fractured.The procedure was completed with another of the same stent and the patient condition following the procedure was stable.
Event or Problem Description
It was reported that during insertion, resistance was felt at the front end of the stent, and folds were observed at the back end of the stent.The pigtail at the bladder end of the ureteral stent was torn.The procedure was completed with another of the same stent and the patient condition following the procedure was stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable investigation results of stent kinked, inside the patient.Imdrf device code a0414 captures the reportable investigation results of stent torn material, inside the patient.Block b5 and h6 has been updated based on additional information was received on january 26, 2025.Block h11: block h6 device code has been corrected.
Event or Problem Description
It was reported that during insertion, resistance was felt at the front end of the stent, and folds were observed at the back end of the stent.The pigtail at the bladder end of the ureteral stent was fractured.The procedure was completed with another of the same stent and the patient condition following the procedure was stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable investigation results of stent kinked, inside the patient.Imdrf device code a0414 captures the reportable investigation results of stent torn material, inside the patient.The percuflex ureteral stent was returned for analysis, additionally, the pouch returned, however the suture and the positioner were not returned.During the visual and magnification inspection, it was found that the stent bladder coil with a torn from the drainage hole to suture hole, and the tip of the stent coil bladder was buckle.No kinks were observed.The reported event of stent kink will not be confirmed and was selected as no problem detected because, after visual and, magnification inspections in the complaint device, it was not possible to identify any evidence of kinks on the device.However, the reported event of stent torn material will be confirmed.During the inspection was found the stent bladder coil with a torn from the drainage hole to suture hole, and the tip of the stent coil bladder was buckled.It is possible to conclude that this issue could be caused by operational factors.If the positioner is advanced with excess force over the guidewire the stent can get buckled or accordioned resulting in a difficulty or unable to advance the stent to the target site.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 the event.

• Brand Name: PERCUFLEX
• 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
• MDR Report Key: 21164032
• Report Number: 2124215-2024-83855
• Device Sequence Number: 21217032
• Product Code: FAD
• UDI-Device Identifier: 08714729040279
• UDI-Public: 08714729040279
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K834468
• 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,Followup,Followup
• Report Date (Section B): 03/28/2025

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: M0061453520
• Device Catalogue Number: 145-352
• Device Lot Number: 0033662750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 01/26/2025; 03/10/2025
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 02/19/2025; 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 59 KG