MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX PLUS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	0025523106
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Tract Infection (2120)
Date of Event	02/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a percuflex ureteral stent was implanted during a laser lithotripsy procedure in the left ureter on (b)(6) 2022, as part of the u0652 double-j registry clinical study.On (b)(6) 2022, the stent was successfully implanted, and a medication of acetaminophen tylenol, alpha blocker, zofran and anticholinergic was given for the patient's left flank pain.On (b)(6) 2022, it was noted that the stent was removed successfully, and pain control was not required.On (b)(6) 2022, the event was considered resolved.
Additional Manufacturer Narrative
Report source: study; u0652 double-j registry clinical study.(b)(4).
Additional Manufacturer Narrative
Block g3: study: u0652 double-j registry clinical study.Block h6: patient code 9205 captures the reportable event of pain.Block h11: additional information.Block b5 has been updated based on the additional information received on november 01, 2022.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex ureteral stent was implanted during a laser lithotripsy procedure in the left ureter on (b)(6) 2022, as part of the u0652 double-j registry clinical study.On (b)(6) 2022, the stent was successfully implanted, and a medication of acetaminophen tylenol, alpha blocker, zofran and anticholinergic was given for the patient's left flank pain.On (b)(6) 2022, it was noted that the stent was removed successfully, and pain control was not required.On february 14, 2022, the event was considered resolved.Additional information received on november 1, 2022, stating that the stent was not removed at the time of the adverse event.The adverse event onset dates are noted as february 7,2022, which was the same date as the stent removal procedure however, the adverse event occurred prior to the stent removal procedure.
Additional Manufacturer Narrative
Block g3: study: u0652 double-j registry clinical study.Block h6: patient code 9205 captures the reportable event of pain.Block h11: block b5 has been updated based on the additional information received on february 22, 2023.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex ureteral stent was implanted during a laser lithotripsy procedure in the left ureter on (b)(6) 2022, as part of the u0652 double-j registry clinical study.On (b)(6) 2022, the stent was successfully implanted, and a medication of acetaminophen tylenol, alpha blocker, zofran and anticholinergic was given for the patient's left flank pain.On (b)(6) 2022, it was noted that the stent was removed successfully, and pain control was not required.On (b)(6) 2022, the event was considered resolved.Additional information received on november 1, 2022, stating that the stent was not removed at the time of the adverse event.The adverse event onset dates are noted as (b)(6) 2022, which was the same date as the stent removal procedure however, the adverse event occurred prior to the stent removal procedure.Additional information received on february 22, 2023, reported that the stop date for the event of left flank pain was on (b)(6) 2022.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex ureteral stent was implanted during a laser lithotripsy procedure in the left ureter on (b)(6) 2022, as part of the u0652 double-j registry clinical study.On (b)(6) 2022, the stent was successfully implanted, and a medication of acetaminophen tylenol, alpha blocker, zofran and anticholinergic was given for the patient's left flank pain.On (b)(6) 2022, it was noted that the stent was removed successfully, and pain control was not required.On (b)(6) 2022, the event was considered resolved.Additional information received on november 1, 2022, stating that the stent was not removed at the time of the adverse event.The adverse event onset dates are noted as (b)(6) 2022, which was the same date as the stent removal procedure however, the adverse event occurred prior to the stent removal procedure.Additional information received on february 22, 2023, reported that the stop date for the event of left flank pain was on (b)(6) 2022.Additional information received on march 14, 2023, in the event of pyelonephritis with an onset date of (b)(6) 2022, with moderate severity and hospitalized from (b)(6) 2022, to (b)(6) 2022.The patient was given a medication of ceftriaxone and underwent ct scan on (b)(6) 2022, and was resolved on (b)(6) 2022.The procedure relationship is probably related, and the device relationship, stent removal relationship were both determined to be possibly related as well.
Additional Manufacturer Narrative
Block g3: study: u0652 double-j registry clinical study.Block h6: imdrf patient code e2330 captures the reportable event of pain.Imdrf patient code e1310 captures the reportable event of pyelonephritis.Imdrf patient code f2303 captures the reportable event of medication required.Imdrf patient code f08 captures the reportable event of hospitalization.Block h11: blocks b5 and h6 have been updated based on the additional information received on march 14, 2023.

• Brand Name: PERCUFLEX PLUS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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: 15839825
• Report Number: 3005099803-2022-06665
• Device Sequence Number: 14914457
• Product Code: FAD
• UDI-Device Identifier: 08714729056805
• UDI-Public: 08714729056805
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K924608
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/04/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/19/2023
• Device Model Number: 0025523106
• Device Catalogue Number: 175-252
• Device Lot Number: 0025523106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/27/2022
• Supplement Date Received by Manufacturer: 11/01/2022; 02/22/2023; 03/14/2023
• Initial Report FDA Received Date: 11/21/2022
• Supplement Report FDA Received Date: 11/28/2022; 03/14/2023; 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female