MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTOUR; STENT, URETERAL

Model Number	M0061802230
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Abdominal Pain (1685); Hematuria (2558)
Date of Event	09/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient went to the hospital on (b)(6) 2024 with left lumbar and abdominal pain for one day.The patient underwent transurethral holmium laser lithotomy of the lower left ureter under combined lumbar and epidural anesthesia on (b)(6) 2024.A 6f ureteral stet was indwelled after the operation.On (b)(6) 2024, it was noted that the ureteral stent was displaced, and blood was present in the patient's urine.The patient was restented and given a hemostatic treatment with injectable sodium carboxysulfone.On (b)(6) 2024 the patient was hematuria free, and their symptoms had resolved.
Additional Manufacturer Narrative
Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e1002 captures the reportable event of abdominal pain.Imdrf patient code e1302 captures the reportable event of hematuria.Imdrf impact code f2303 captures the reportable event of medication required.

• Brand Name: CONTOUR
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 20737929
• Report Number: 2124215-2024-71313
• Device Sequence Number: 18296158
• Product Code: FAD
• UDI-Device Identifier: 08714729058533
• UDI-Public: 08714729058533
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2024

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: M0061802230
• Device Catalogue Number: 180-223
• Device Lot Number: 0033138376
• 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: 10/25/2024
• Initial Report FDA Received Date: 11/20/2024
• Date Device Manufactured: 01/04/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female