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

Model Number	M0061752630
Medical Device Problem Codes	Break (1069); 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	03/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was intended to be used in a flexible ureteroscope lithotripsy procedure in the left renal for pelvic stone management performed on (b)(6) 2023.During preparation, it was found that the stent was fractured.The procedure was successfully completed with another percuflex plus ureteral stent.A photo of the complaint device was provided and showed that the stent had a tear and the shaft was broken.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.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a flexible ureteroscope lithotripsy procedure in the left renal for pelvic stone performed on (b)(6) 2023.During unpacking, it was found that the stent was fractured.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.A photo of the complaint device was provided and showed that the stent shaft was 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 stent bladder coil was detached.The positioner was not returned, the suture was returned loaded in the stent and entangled in the renal coil.It is important to mention that the returned device is in different conditions than the photo attached.During a functional inspection, a mandrel of 0.039 as used and pass through the stent without resistance.No other problems with the device were noted.The reported event was not 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 and or an entanglement could have contributed to the problem, also is possible that an interaction with excess of force between the device and the suture generated some tension during the setting up contributing to the found issues.Consequently, affect the performance of the device.It has not been confirmed that there was a stent shaft break or stent torn material issue, as no break or tear was detected.Therefore, the root cause code will be no problem detected.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 preparation 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: 16703255
• Report Number: 3005099803-2023-01642
• Device Sequence Number: 5669672
• Product Code: FAD
• UDI-Device Identifier: 08714729041184
• UDI-Public: 08714729041184
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/03/2023

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: 02/21/2025
• Device Model Number: M0061752630
• Device Catalogue Number: 175-263
• Device Lot Number: 0028913576
• 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: 03/13/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2022
• 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: 42 YR
• Patient Sex: Male
• Patient Weight: 75 KG