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

Model Number	M001235600
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The interventional radiologist scheduled the patient for a procedure during which he intended to remove the patient's left nephroureteral catheter and replace it with a double-j stent.The physician had successfully removed the nephroureteral catheter over a guidewire and then placed an 11 french peel-away sheath.A 10 french by 26-cm double-j stent was then advanced over the guidewire.After deployment of the stent, it promptly migrated distally with the deformed proximal retention loop "kinking" in the ureter approximately 5-7 cm from the renal pelvis.The external retention "suture" was found to be unassociated/detached from the proximal aspect of the double j stent upon applying tension to it.Extensive attempts to reposition the stent using vascular snares and multiple catheter and guidewire combinations were attempted but were unsuccessful.The stent could not be appropriately engaged at its proximal aspect.Multiple attempts were made at passage of a guidewire into the stent, without success.Therefore, a guidewire was advanced into the urinary bladder and a vascular snare was used to engage the distal aspect of the double-j stent within the urinary bladder.A second 5 french catheter was advanced into the urinary bladder in an attempt to maintain access.The distal aspect of the stent was then withdrawn through the ureter into the renal pelvis.During attempts at removing the double-j stent completely, the snare severed the double-j stent approximately midway from the skin entry site and the entry site to the renal capsule.Limited attempts were made through the existing minimal incision to dissect down onto the stent remnant for removal.The could not be successfully achieved, so the procedure was modified and completed with the stent remnant remaining inside the patient.
Event or Problem Description
The interventional radiologist scheduled the patient for a procedure during which he intended to remove the patient's left nephroureteral catheter and replace it with a double-j stent.The physician had successfully removed the nephroureteral catheter over a guidewire and then placed an 11 french peel-away sheath.A 10 french by 26-cm double-j stent was then advanced over the guidewire.After deployment of the stent, it promptly migrated distally with the deformed proximal retention loop "kinking" in the ureter approximately 5-7 cm from the renal pelvis.The external retention "suture" was found to be unassociated/detached from the proximal aspect of the double j stent upon applying tension to it.Extensive attempts to reposition the stent using vascular snares and multiple catheter and guidewire combinations were attempted but were unsuccessful.The stent could not be appropriately engaged at its proximal aspect.Multiple attempts were made at passage of a guidewire into the stent, without success.Therefore, a guidewire was advanced into the urinary bladder and a vascular snare was used to engage the distal aspect of the double-j stent within the urinary bladder.A second 5 french catheter was advanced into the urinary bladder in an attempt to maintain access.The distal aspect of the stent was then withdrawn through the ureter into the renal pelvis.During attempts at removing the double-j stent completely, the snare severed the double-j stent approximately midway from the skin entry site and the entry site to the renal capsule.Limited attempts were made through the existing minimal incision to dissect down onto the stent remnant for removal.The could not be successfully achieved, so the procedure was modified and completed with the stent remnant remaining inside the patient.

• Brand Name: PERCUFLEX¿
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 16536613
• Report Number: 16536613
• Device Sequence Number: 5945837
• Product Code: FAD
• UDI-Device Identifier: 08714729031857
• UDI-Public: (01)08714729031857(17)230721(10)25746917
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023
• Report Date (Section F): 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M001235600
• Device Catalogue Number: M001235600
• Device Lot Number: 25746917
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2023
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 03/15/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Race: White
• Date Report Sent to FDA: 02/27/2023