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

Model Number M0061801550

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 12/22/2021

Event Type  Injury  

Manufacturer Narrative

(b)(6).(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 Description

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 u0652 double-j registry clinical 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 stent 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
• Type of Device: 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: 13486890
• MDR Text Key: 288997473
• Report Number: 3005099803-2022-00463
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729058410
• UDI-Public: 08714729058410
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2022

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
• Device Operator: Health Professional
• Device Model Number: M0061801550
• Device Catalogue Number: 180-155
• Device Lot Number: 0027977826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 84 KG