MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDEX SOFT DOUBLE PIGTAIL STENT WITH SUTURE AND LUBRIWIRE, OPEN TIP, SINGLE USE; SUTURE STENT

Catalog Number 090626SL

Device Problem Knotted (1340)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: "indications for use: bardex® double pigtail ureteral stent with suture is indicated for relief of obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter.The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique.The bardex® double pigtail ureteral stent kit contains the following: one ureteral indwelling stent with suture; 1 hydro-glide¿ guidewire; 1 push catheter; 1 stent clamp; 1 directions for use.Directions for use: (open end): prior to removing guidewire from hoop, inject sterile water through port to activate lubricious coating.Pass the guidewire flexible tip beyond the obstruction to the renal pelvis.Note: tortuosity in the obstructed ureter can often be resolved using the guidewire and open end ureteral catheter in combination.Estimate the proper stent length, generally from the baseline pyelogram.Add 1cm to that ureteral measurement.Drainage efficiency and patient comfort are enhanced by accurate measurement.Pass the stent over the guidewire through the cystoscope, advancing it into the ureter with the push catheter under direct vision.Assistant should hold the guidewire in position to prevent advancement of the wire into the renal parenchyma.Watch for the distal end of the stent at the ureterovesical junction.Stop advancement of the stent at that point.Assistant should remove the guidewire as the operator holds the stent in position with the push catheter.The stent pigtail will form spontaneously.Carefully remove the push catheter from the cystoscope.Preloaded stent with clamp: remove the hydro-glide¿ guidewire from the stent package.Place guidewire into distal (bladder) end of stent.Advance guidewire to the proximal end of the stent.If stiff end of guidewire is used, do not allow guidewire tip to extend past proximal tip of stent.(this will keep stent in place for insertion.) place push catheter on guidewire until it abuts distal end of stent.Place small white clamp at most distal end of push catheter and clamp securely.This will ensure correct positioning of stent on the push catheter during insertion procedure.Insert stent.When placement is complete, release clamp by pushing top portion back and remove from push catheter.From push catheter.Hold push catheter and remove guidewire.The stent retention loop will form spontaneously.Then carefully remove push catheter from cystoscope.Note: final adjustment, if necessary, can be made with endoscopic forceps.Stents can be removed easily by gentle withdrawal traction on the suture or by use of endoscopic forceps.Fluoroscopy facilitates stent placement; however, standard radiography may be used.The suture may be removed prior to placement or may be removed once indwelling by using an appropriate cystoscopic instrument.Precautions: for single use only.Do not resterilize.Do not use if the package or product is damaged.2 improper handling technique can seriously weaken the stent.Acute bending or overstressing during placement could result in subsequent separation of the stent at the point of stress after a prolonged indwelling period.Remove suture prior to placement for pediatric patients.Exercise care.Tearing of the stent can be caused by sharp instruments.All stents will be subjected to varying degrees of encrustation when placed in the urinary tract.Periodic checks of the stent by cystoscopic and radiographic means are recommended.When encrustation is severe enough to potentially occlude the stent, replace it with a new one.It is recommended that a single stent not remain indwelling more than four (4) weeks.The stent may be replaced with a new stent if the patient¿s status permits.Care should be exercised when removing the stent so as not to cause tearing or fragmentation.With any ureteral stent, migration is a possible complication which could require medical intervention for removal.Selection of too short a stent may result in migration.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and with applicable local, state, and federal laws and regulations." (b)(4).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.

Event Description

It was reported that the string was knotted too tightly around the device.However, the device was used on the patient with no impact to the patient or procedure.

• Brand Name: BARDEX SOFT DOUBLE PIGTAIL STENT WITH SUTURE AND LUBRIWIRE, OPEN TIP, SINGLE USE
• Type of Device: SUTURE STENT
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6429476
• MDR Text Key: 70998848
• Report Number: 1018233-2017-01295
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K883561
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/23/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 090626SL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/23/2017
• 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