MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX NEPHROURETERAL STENT; TUBE, DRAINAGE, SUPRAPUBIC

Model Number	35375
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was returned for evaluation.A visual inspection confirmed that the stent was crushed and torn, also the suture was detached.The attached media observed that the stent was crushed.No other issues were identified with the device and no patient complications were reported.
Event or Problem Description
Reportable based on device analysis completed on 26-sep 2024.It was reported that the nephroureteral tube was crimped.An ie temp tip 10/26 other urinary was selected for a nephroureteral tube placement.When the package had been opened, it was discovered that the tube was crimped.The procedure was completed using an alternative device.There were no patient complications reported.However, device analysis revealed that the stent was crushed and torn, and the suture was detached.

• Brand Name: PERCUFLEX NEPHROURETERAL STENT
• Common Device Name: TUBE, DRAINAGE, SUPRAPUBIC
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20495477
• Report Number: 2124215-2024-64661
• Device Sequence Number: 19877486
• Product Code: FAD
• UDI-Device Identifier: 08714729031703
• UDI-Public: 08714729031703
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2024

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: 35375
• Device Catalogue Number: 35375
• Device Lot Number: 0033490091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2024
• 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: Unknown