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

Model Number M0061752620

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

Patient Problem Pain (1994)

Event Date 03/07/2022

Event Type  Injury  

Manufacturer Narrative

Report source: study: u0652 double-j registry clinical study.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a previously implanted percuflex plus ureteral stent was removed from the left ureter, performed on (b)(6) 2022 as part of the u0652 double-j registry clinical study.On (b)(6) 2022, the percuflex plus ureteral stent was successfully placed for stone management in the left ureter, and the patient was prescribed the discharge medications, acetaminophen (tylenol) and non steroidal anti inflammatory drugs (nsaid)s.No issues were noted with the device.On (b)(6) 2022, the patient had experienced a left flank pain.The patient was given toradol, morphinr, iv fluids, norco, keflex, cipro to treat the pain.During the planned stent removal performed on (b)(6) 2022, the percuflex plus ureteral stent was successfully removed from the patient without any difficulty.There was no new device implanted.On (b)(6) 2022 the event was considered resolved.

Manufacturer Narrative

Block g3: study: u0652 double-j registry clinical study.Block h6: medical problem code e2330 is being used to capture the reportable issue of pain.Block h10: block b5 have been updated based on additional information received october 31, 2022.

Event Description

It was reported to boston scientific corporation that a previously implanted percuflex plus ureteral stent was removed from the left ureter, performed on (b)(6) 2022, as part of the u0652 double-j registry clinical study.On (b)(6) 2022, the percuflex plus ureteral stent was successfully placed for stone management in the left ureter, and the patient was prescribed the discharge medications, acetaminophen (tylenol) and non-steroidal anti-inflammatory drugs (nsaid)s.No issues were noted with the device.On march 11, 2022, the patient had experienced a left flank pain.The patient was given toradol, morphinr, iv fluids, norco, keflex, cipro to treat the pain.During the planned stent removal performed on (b)(6) 2022, the percuflex plus ureteral stent was successfully removed from the patient without any difficulty.There was no new device implanted.On (b)(6) 2022, the event was considered resolved.Additional information received that the onset date was on march 7, 2022, and the procedure outcome was unknown.The event of moderate left-sided flank pain, requiring treatment with medication and hospitalization, and reported to be probably related to the procedure, probably related to the device and not related to stent removal.

• 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: 14455557
• MDR Text Key: 292172163
• Report Number: 3005099803-2022-02554
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729056829
• UDI-Public: 08714729056829
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/23/2022

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: M0061752620
• Device Catalogue Number: 175-262
• Device Lot Number: 0028530317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2022
• Initial Date FDA Received: 05/20/2022
• Supplement Dates Manufacturer Received: 10/31/2022
• Supplement Dates FDA Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2021
• 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: 30 YR
• Patient Sex: Female