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

Model Number UNK-P-PERCUFLEX_PLUS

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

Patient Problems Discomfort (2330); Dysuria (2684)

Event Date 07/15/2021

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Study: u0652 double-j registry clinical study.(b)(4).

Event Description

Note: this report is one of two complaints that pertain to the same event (mfr report #3005099803-2022-0734 and mfr.Report #3005099803-2022-07342).It was reported to boston scientific corporation that a percuflex plus ureteral stents were used in a stent placement procedure for benign obstruction in the right ureter performed on (b)(6) 2021, as part of the u0652 double-j registry clinical study.During the procedure, two percuflex plus ureteral stents were implanted retrograde under fluoroscopy.The stents were successfully implanted.The procedure was performed without any complications.Discharge medications included alpha blocker and narcotic analgesics (opioids).On (b)(6) 2021, a planned stent removal procedure was performed.Pain control was not required.Stents were not difficult to remove and were successfully removed at this attempt.It was reported that the patient had experienced mild stent colic and mild dysuria while the stent was still implanted in the patient for 24 days.The patient was prescribed with tylenol and codeine as treatment for dysuria.The adverse events were reported to have been resolved on (b)(6) 2021.In the physician's assessment, the relationship between the procedure, the device and the event is possibly related.

• Brand Name: PERCUFLEX PLUS SUREDRIVE
• 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: 15978930
• MDR Text Key: 305445988
• Report Number: 3005099803-2022-07341
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2022

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: UNK-P-PERCUFLEX_PLUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 63 YR
• Patient Sex: Female