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

Model Number	M0061801550
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	01/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source: clinical study: (b)(4) (b)(6) registry.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
Note: this report is one of two complaints that pertain to the same event (mfr report # 3005099803-2022-00463 and mfr.Report # 3005099803-2022-00462).It was reported to boston scientific corporation that a double-j contour ureteral stents were used during a stent placement procedure in the left and right ureter under flouroscopy and cystoscopy, performed on (b)(6) 2021 as part of the (b)(4) (b)(6)study.The stent placement procedure was indicated for renal papillary necrosis.On (b)(6) 2021, the left and right side stent was successfully implanted to the patient.The patient was prescribed with acetaminophen (tylenol), antibiotic and narcotic analgesics (opioids) at discharge.No issues were noted with the devices.Post procedure, on (b)(6) 2021, moderate flank pain was experienced by the patient.Oxycodone and oxybutynin 5mg were given as medication for pain.The event was considered to be resolved as of (b)(6) 2022.On (b)(6) 2022, the stents were removed successfully in the operating room as per initial plan.Stents were not difficult to remove.Pain control (general anesthesia) was required during stent removal.There were no new stents implanted.In the physician's assessment, the relationship between the procedure and the event is possibly related, there is no relationship between the adverse event and the bsc guidewire, the stent implant procedure, and the stent removal procedure as 'not related' relationship between the adverse event.

• Brand Name: CONTOUR VL
• 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: 13474366
• Report Number: 3005099803-2022-00462
• Device Sequence Number: 17175871
• Product Code: FAD
• UDI-Device Identifier: 08714729058410
• UDI-Public: 08714729058410
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/05/2024
• Device Model Number: M0061801550
• Device Catalogue Number: 180-155
• Device Lot Number: 0027794686
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 02/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2021
• 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: 34 YR
• Patient Sex: Male
• Patient Weight: 84 KG