FDA Adverse Event Injury Summary report: N

PERCUFLEX

MDR report key: 16694189 · Received April 6, 2023

Report

Report Number
2124215-2023-14396
Event Type
Injury
Date Received
April 6, 2023
Date of Event
February 8, 2023
Report Date
April 6, 2023
Manufacturer
BOSTON SCIENTIFIC CORPORATION
Product Code
FAD
UDI-DI
08714729031857
PMA / PMN Number
K924608
Adverse Event
Yes
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
MI, US
Reporter Occupation
003

Narratives

Description of Event or Problem · 0

IT WAS REPORTED VIA ATTACHED MEDWATCH (B)(4) THAT STENT WAS DIFFICULT TO POSITION AND SUTURE DETACHMENT OCCURRED WHICH REQUIRED ADDITIONAL INTERVENTION. A PERCUFLEX URETERAL STENTS WAS USED IN THE URETER. DURING THE PROCEDURE, THE NEPHROURETERAL CATHETER WAS SUCCESSFULLY REMOVED 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 THE DISTAL ASPECT OF THE STENT WAS THEN WITHDRAWN THROUGH THE URETER INTO THE RENAL PELVIS.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. HOWEVER, IT COULD NOT BE SUCCESSFULLY ACHIEVED, SO THE PROCEDURE WAS MODIFIED AND COMPLETED WITH THE STENT REMNANT REMAINING INSIDE THE PATIENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1820716 PERCUFLEX TUBE, DRAINAGE, SUPRAPUBIC FAD BOSTON SCIENTIFIC CORPORATION 1094-03 0025746917 08714729031857

Patients

Seq Age Sex Outcome Treatment
1 73 YR Male Required Intervention