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

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

Patient Problems Pain (1994); Hematuria (2558); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/01/2023

Event Type  Injury  

Manufacturer Narrative

Block b3: exact date unknown.The provided event date was approximated based on the clinic visit around (b)(6) 2021.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block g2 (report source): study: boston scientific urology case report (b)(4).Block h6: imdrf patient code e2330 captures the reportable event of pain.Imdrf impact code f2301 captures the reportable event of additional device required.

Event Description

Boston scientific corporation became aware of the event through the article 'a double-j stent misguided by zebra guidewire into ileum: a case report and literature review', by liangcheng liu, guihua cao, guimin huang, jianping du, wei li, qiang li.According to the article, the patient was experiencing painless macroscopic hematuria, and lower abdominal dissention during a six-month period.The patient underwent a laparoscopic left nephro-ureterectomy and contralateral end cutaneous ureterostomy, with regular double-j stenting every 3 months for the patient's stomal stenosis.Three months after the surgery the patient unintentionally pulled out their double-j stent and presented to the outpatient clinic with back pain in the right side.A double-j stent was inserted into the right cutaneous ureterostomy by boston scientific zebra without blatant obstruction, and the patient had no discomfort.The replacement stent is covered under the mfr report # 2124215-2023-61256 and is associated with patient complications resulting in patient death.

• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112 ; 5086834015
• MDR Report Key: 18108102
• MDR Text Key: 327870414
• Report Number: 2124215-2023-61965
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male