MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX PLUS SUREDRIVE; STENT, URETERAL

Model Number	M0061457490
Medical Device Problem Codes	Entrapment of Device (1212); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific that a percuflex plus ureteral stent was used during stone removal procedure in the kidney, performed on (b)(6) 2023.On (b)(6) 2023, a second procedure to remove stones was performed.During this procedure, it was noticed that the upper coil of the implanted stent was not completely coiled in the pelvis.The physician had difficulty in getting the guidewire through implanted stent to remove the stent and kidney stones.The stent was successfully removed without difficulty and a new percuflex plus ureteral stent was implanted and successfully completed the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a04 captures the reportable event of coil, coil memory during stent removal.

• Brand Name: PERCUFLEX PLUS SUREDRIVE
• Common Device Name: STENT, URETERAL
• 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: 16894534
• Report Number: 3005099803-2023-02450
• Device Sequence Number: 6141373
• Product Code: FAD
• UDI-Device Identifier: 08714729903031
• UDI-Public: 08714729903031
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0061457490
• Device Catalogue Number: 64183
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male