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

Model Number M001235600

Device Problems Positioning Failure (1158); Entrapment of Device (1212); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981); Migration (4003); Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/08/2023

Event Type  malfunction  

Event 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catheter was advanced into the urinary bladder in an attempt to maintain access.The distal aspect of the stent was then withdrawn through the ureter into the renal pelvis.During attempts at removing the double-j stent completely, the snare severed the double-j stent approximately midway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 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¿
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 16536613
• MDR Text Key: 311226795
• Report Number: 16536613
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729031857
• UDI-Public: (01)08714729031857(17)230721(10)25746917
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 02/27/2023,02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 02/27/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Sex: Male
• Patient Race: White