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

Model Number	M006175263010
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a percuflex plus ureteral stent was used during a urology stenting procedure in the ureter performed on (b)(6) 2023.During preparation, it was noted that the stent became broken when the suture was removed.It was reported that the stent shaft was broken into two pieces.The procedure was successfully completed with another percuflex plus ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of stent shaft broken.
Event or Problem Description
It was reported that a percuflex plus ureteral stent was used during a urology stenting procedure in the ureter performed on (b)(6) 2023.During preparation, it was noted that the stent became broken when the suture was removed.It was reported that the stent shaft was broken into two pieces.The procedure was successfully completed with another percuflex plus ureteral stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.Correction to device and component code: additional information received that the stent coil was detached.Block h10: the returned percuflex plus ureteral stent was analyzed, and a visual evaluation noted that the bladder coil was detached.The suture, positioner and the detached part was not returned, however their respective axxcess catheter and guidewire inside their original pouches were in good condition.A functional test was performed and used a mandrel of 0.039" and the stent pass through without resistance.During magnification, it was observed closely that the section of the device was detached.No other problems with the device were noted.The reported event was confirmed.Based on the most relevant information of the complaint event description, device analysis and including the product record review results, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.According to the evidence, it is possible that operational factors, interaction of the excess force during interaction with the suture string such as an entanglement before their use could have caused the detachment that was observed.Consequently, affect the performance of the device.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 event.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16535607
• Report Number: 3005099803-2023-01278
• Device Sequence Number: 6325931
• Product Code: FAD
• UDI-Device Identifier: 08714729302032
• UDI-Public: 08714729302032
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023

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 Expiration Date: 07/14/2025
• Device Model Number: M006175263010
• Device Catalogue Number: 175-263-01
• Device Lot Number: 0030115418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/15/2022
• 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 Sex: Male