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

Model Number	145-351
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of stent torn material, inside the patient.
Event or Problem Description
It was reported that during the procedure, the lower pigtail band was found fractured when the stent tried to be placed.It was noted that the stent was torn.The procedure was completed with another of the same stent and no patient complications were reported.
Additional Manufacturer Narrative
Block h6: imdrf device code a0414 captures the reportable event of stent torn material, inside the patient.Block h11: the returned percuflex plus ureteral stent was analyzed.A magnification and visual evaluation noted that the bladder coil was detached.The detached piece of the bladder coil was torn from one drainage hole until the suture hole.It was noted that the bladder coil was buckled.Additionally, the suture and positioner were not returned.No other problems with the device were noted.The reported event of stent torn, inside the patient was confirmed.Based on the analysis, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.Regarding to the analysis performed to the returned device evidence of stent coil buckled, it is possible to conclude that this problem could be caused by operational factors, interaction of the device between the positioner and the guide wire while the device was pushing up, such as excess of force applied over the device during the procedure could have contributed to the failure, consistently leading to device being buckled.For that reason, the as analyzed cause code will be adverse event related to procedure.For the reported event of stent torn, these failures 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.Consequently, affect the performance of the device.Therefore, 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 that during the procedure, the lower pigtail band was found fractured when the stent tried to be placed.It was noted that the stent was torn.The procedure was completed with another of the same stent and no patient complications were reported.

• 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: 20326783
• Report Number: 2124215-2024-58426
• Device Sequence Number: 7903061
• Product Code: FAD
• UDI-Device Identifier: 08714729040262
• UDI-Public: 08714729040262
• 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
• Report Date (Section B): 12/06/2024

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: 06/01/2025
• Device Model Number: 145-351
• Device Catalogue Number: 145-351
• Device Lot Number: 0029519450
• 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: 09/03/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 65 KG