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

Model Number	M0061457490
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blocks 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: device problem code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that, during a ureteroscopy procedure, a perculfex plus stent was going to be used.During preparation, the stent shaft was found broken in the middle.Another percuflex plus with suredrive was opened to successfully complete the procedure.No patient complications were reported.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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 IN 47460 ; CS 47460
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 19943581
• Report Number: 2124215-2024-48886
• Device Sequence Number: 4877065
• Product Code: FAD
• UDI-Device Identifier: 08714729903031
• UDI-Public: 08714729903031
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K974541
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/08/2024

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 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): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 08/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown