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

Model Number	M0061458630
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a previously implanted contour ureteral stent was removed from the left ureter, performed on (b)(6) 2022, as a part of the u0652 double-j registry clinical study.The contour ureteral stent was placed retrograde on the left side under fluoroscopy and cystoscopy on (b)(6) 2022, with no problems reported during placement.On (b)(6) 2022, the patient had a left renal lithiasis and was hospitalized under ureteral interventional procedure until (b)(6) 2022.On (b)(6) 2022, the contour ureteral stent was successfully removed from the patient in the operating room.No issues were reported with the device during removal.The patient was given a medication of morphine 10 mg/ml, ketoprofen 100 mg/4ml.On (b)(6) 2022, the event was considered resolved.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a previously implanted contour ureteral stent was removed from the left ureter, performed on (b)(6) 2022, as a part of the u0652 double-j registry clinical study.The contour ureteral stent was placed retrograde on the left side under fluoroscopy and cystoscopy on (b)(6) 2022, with no problems reported during placement.On (b)(6) 2022, the patient had a left renal lithiasis and was hospitalized under ureteral interventional procedure until (b)(6) 2022.On (b)(6) 2022, the contour ureteral stent was successfully removed from the patient in the operating room.No issues were reported with the device during removal.The patient was given a medication of morphine 10 mg/ml, ketoprofen 100 mg/4ml.On (b)(6) 2022, the event was considered resolved.There were no patient complications reported as a result of this event.Additional information received on march 3, 2023, reported an event of kidney pain with an onset date of july 18, 2022.The severity was mild, and the patient was hospitalized, as previously reported, from (b)(6) 2022.The clavien-dindo classification was noted to be grade i.The actions taken included, as previously reported, morphine 10 mg/ml, ketoprofen 100mg/4ml; hospitalization; ureteral interventional procedure- uretherosopy (ureteroscopy) for stone fragment removal.The event was resolved as of (b)(6) 2022.The event was noted to be possibly related to the device.
Additional Manufacturer Narrative
Block h6: imdrf device code a040501 captures the reportable event of stent calcified.Imdrf patient code e2330 captures the reportable event of pain.Block h10: block b5 has been updated based on additional information received on march 3, 2023.Correction: section e1-e4 initial reporter have been corrected.

• Brand Name: CONTOUR 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 ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15890299
• Report Number: 3005099803-2022-06903
• Device Sequence Number: 17840964
• Product Code: FAD
• UDI-Device Identifier: 08714729903185
• UDI-Public: 08714729903185
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2023

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 Expiration Date: 03/03/2023
• Device Model Number: M0061458630
• Device Catalogue Number: 64441
• Device Lot Number: 0026268934
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2022
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2020
• 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: 32 YR
• Patient Sex: Female