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

Model Number M0061752630

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

Patient Problems Pain (1994); Hematuria (2558)

Event Date 03/09/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was used in a stent placement procedure for stone management, laser lithotripsy in the right ureter performed on (b)(6) 2022 as part of the u0652 double-j registry clinical study.On (b)(6) 2022, the stent was placed retrograde on the right side of the ureter under cystoscopy and fluoroscopy.Bsc guidewires and ureteral access sheath were used and the stent was successfully implanted with no device deficiencies or adverse event attributed.Discharge medications of alpha blocker, anticholinergic, narcotic analgesics (opioids), and phenazopyridine were given to the patient.According to the complainant, post procedure, on (b)(6) 2022, the patient had experienced mild right flank pain.The patient was given levsin to treat the pain.There was no information if the event of pain has been resolved.On (b)(6), the patient has also experienced mild hematuria.There was no action or medication given to treat the mild hematuria and there was no information if the event of mild hematuria has been resolved.On the same day, a planned stent removal procedure was also performed as per the initial plan.Pain control was not required and stent was not difficult to remove and was removed at this attempt.There were no new device implanted.No issues were noted with the devices during removal.In the physician's assessment, the data reasonably suggest the clinical events mild right flank pain assessed as not related to the procedure and causally related to the device, and mild hematuria assessed as possibly related to the procedure and probably related to the device, are anticipated in nature and severity as per the ifu and hazard analysis.

Manufacturer Narrative

Block h6: patient code e2330 captures the reportable event of pain.Impact code f2303 captures the reportable event of medication required.Block h11: updated b5, additional information received on 14oct2022.

Event Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was used in a stent placement procedure for stone management, laser lithotripsy in the right ureter performed on (b)(6) 2022 as part of the u0652 double-j registry clinical study.On (b)(6) 2022, the stent was placed retrograde on the right side of the ureter under cystoscopy and fluoroscopy.Bsc guidewires and ureteral access sheath were used and the stent was successfully implanted with no device deficiencies or adverse event attributed.Discharge medications of alpha blocker, anticholinergic, narcotic analgesics (opioids), and phenazopyridine were given to the patient.According to the complainant, post procedure, on (b)(6) 2022, the patient had experienced mild right flank pain.The patient was given levsin to treat the pain.There was no information if the event of pain has been resolved.On (b)(6), the patient has also experienced mild hematuria.There was no action or medication given to treat the mild hematuria and there was no information if the event of mild hematuria has been resolved.On the same day, a planned stent removal procedure was also performed as per the initial plan.Pain control was not required and stent was not difficult to remove and was removed at this attempt.There were no new device implanted.No issues were noted with the devices during removal.In the physician's assessment, the data reasonably suggest the clinical events mild right flank pain assessed as not related to the procedure and causally related to the device, and mild hematuria assessed as possibly related to the procedure and probably related to the device, are anticipated in nature and severity as per the ifu and hazard analysis.Additional information received on october 14, 2022, stating that, the mild hematuria was assessed as 'not' related to the procedure and is possibly related to the device.

• Brand Name: PERCUFLEX PLUS
• Type of Device: 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: 15620845
• MDR Text Key: 301909146
• Report Number: 3005099803-2022-05967
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729041184
• UDI-Public: 08714729041184
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K924608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2022

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: M0061752630
• Device Catalogue Number: 175-263
• Device Lot Number: 0028589566
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 10/14/2022
• Supplement Dates FDA Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2021
• 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: 47 YR
• Patient Sex: Female