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

Device Problems Break (1069); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pain (1994); Perforation (2001); Discomfort (2330); Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2021

Event Type  Injury  

Manufacturer Narrative

Age at time of event: 70 years old.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Imdrf device code a0401 captures the reportable event of stent broken.Imdrf patient code e2311 captures the reportable event of discomfort.Imdrf patient code e1906 captures the reportable event of infection.Imdrf patient code e2008 captures the reportable event of unretrieved device fragment.Imdrf patient code e2330 captures the reportable event of pain.

Event Description

It was reported to boston scientific corporation that a ureteral stent was successfully removed during a stent removal procedure in the ureter/kidney performed on (b)(6), 2021.On (b)(6), 2021, the patient underwent a low anterior resection and colostomy takedown.There were two open ended ureteral catheters, placed bilaterally.It was noted that it remained inside the patient for a couple of days due to a bladder laceration.It was noted that the ureter has a stricture from trauma likely related to the fractured stent.The guidewire was unable to pass to do stent placement or balloon dilatation.The patient experienced pain, infection and discomfort.On (b)(6),2021.The two open ended ureteral catheters were successfully removed.The stent placed on the left ureter/kidney was removed without any problem, however, the other stent that was placed on the right was broken approximately 10 centimeters and remained in the ureter/kidney.The procedure was successfully completed.The patient's condition at the conclusion of the procedure was reported to have a disability or permanent damage.

Manufacturer Narrative

Block a2: age at time of event: 70 years old.Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a0401 captures the reportable event of stent broken.Imdrf patient code e2311 captures the reportable event of discomfort.Imdrf patient code e1906 captures the reportable event of infection.Imdrf patient code e2008 captures the reportable event of unretrieved device fragment.Imdrf patient code e2330 captures the reportable event of pain.Block h10: block b5 and h6 have been updated based on additional information received march 16, 2023.Correction: additional information received march 16, 2023 indicated, "the ureter has a stricture from trauma likely related to the fractured stent.Unable to pass a guidewire to do stent placement or balloon dilatation".The fractured stent here is referring to the flexima open-end catheter (previously reported in manufacturer report # 3005099803-2023-01496).Block h6 has been updated to code for e2403 no clinical signs, symptoms or conditions and impact code f26 no health consequences or impact deeming this a non-reportable scenario.Based on the available information, this complaint is for flexima uretheral catheter and not for a percuflex plus stent.Due to the information received, the information reported under manufacturer report # 3005099803-2023-01575 is a duplicate of a previously reported event under manufacturer report # 3005099803-2023-01496.

Event Description

It was reported to boston scientific corporation that a ureteral stent was successfully removed during a stent removal procedure in the ureter/kidney performed on (b)(6) 2021.On (b)(6) 2021, the patient underwent a low anterior resection and colostomy takedown.There were two open ended ureteral catheters, placed bilaterally.It was noted that it remained inside the patient for a couple of days due to a bladder laceration.It was noted that the ureter has a stricture from trauma likely related to the fractured stent.The guidewire was unable to pass to do stent placement or balloon dilatation.The patient experienced pain, infection and discomfort.On (b)(6) 2021.The two open ended ureteral catheters were successfully removed.The stent placed on the left ureter/kidney was removed without any problem, however, the other stent that was placed on the right was broken approximately 10 centimeters and remained in the ureter/kidney.The procedure was successfully completed.The patient's condition at the conclusion of the procedure was reported to have a disability or permanent damage.Based on the additional information received on (b)(6) 2023, "this was an open-ended catheter, not a pigtail.There was no coil".This complaint is for flexima uretheral catheter and not for a percuflex plus stent.

• Brand Name: PERCUFLEX URETERAL STENT
• 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: 16637891
• MDR Text Key: 312244932
• Report Number: 3005099803-2023-01575
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male