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

Model Number M0061752530

Device Problems Calcified (1077); Difficult to Remove (1528)

Patient Problem Pain (1994)

Event Date 08/08/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a ureteral stone lithotripsy procedure to drain urine and prevent ureteral stenosis in the kidney, performed on (b)(6) 2021.On (b)(6) 2022, the patient returned to the hospital to have a planned stent removal procedure.Ct scan indicated that a large number of stones were attached to the ureteral stent catheter and could not be removed.On an elective date, the patient had to be hospitalized to perform a holmium laser procedure to crush the stones and remove the stent.The entire stent was removed by cystoscopy and a new stent of a different model was implanted and successfully completed the procedure.Increased pain was reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.

Manufacturer Narrative

(b)(6).(b)(4).(b)(6).

Event Description

It was reported to boston scientific corporation that a percuflex plus ureteral stent was used during a ureteral stone lithotripsy procedure to drain urine and prevent ureteral stenosis in the kidney, performed on (b)(6) 2021.On august 08, 2022, the patient returned to the hospital to have a planned stent removal procedure.Ct scan indicated that a large number of stones were attached to the ureteral stent catheter and could not be removed.On an elective date, the patient had to be hospitalized to perform a holmium laser procedure to crush the stones and remove the stent.The entire stent was removed by cystoscopy and a new stent of a different model was implanted and successfully completed the procedure.Increased pain was reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be good.Additional information was received on september 05, 2022 stating that the patient experienced pain before and during stent removal procedure and was given diclofenac sodium capsule as medication for pain.The adverse event of pain was resolved on (b)(6) 2022.

Manufacturer Narrative

Block e1: initial reporter facility name: (b)(6).Block h6: medical device problem code a150207 captures the reportable event of stent calcified.Medical device problem code a150205 captures the reportable event stent difficult to remove.Impact code f23 captures the reportable event of unexpected medical intervention.Impact code f2303 captures the reportable event of medication required.Patient code e2330 captures the reportable event of pain.Block h11: initial reporter is unknown, however the contact number is (b)(6).Block b5; block h1 and block h6 have been updated based on the additional information received on august 30, 2022.

• 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: 15351237
• MDR Text Key: 299271930
• Report Number: 3005099803-2022-04829
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729056812
• UDI-Public: 08714729056812
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K924608
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2023
• Device Model Number: M0061752530
• Device Catalogue Number: 175-253
• Device Lot Number: M0061752530
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 09/02/2022
• Supplement Dates Manufacturer Received: 08/30/2022
• Supplement Dates FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• 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: 59 YR
• Patient Sex: Female