MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® FLUORO-4¿ SILICONE URETERAL STENT

Model Number 233624

Device Problems Break (1069); Incorrect Measurement (1383); Failure to Advance (2524)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 stent seemed too narrow and caused the guidewire not to pass through, subsequently the stent broke while trying to remove it from the guidewire.

Event Description

It was reported that the stent seemed too narrow and caused the guidewire not to pass through, subsequently the stent broke while trying to remove it from the guidewire.

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 were found adequate and state the following: "bard® fluoro-4¿ silicone ureteral stent, bard® fluoro-4¿ silicone ureteral coil stent and bard® silicone ureteral coil stent with figure four end information for use caution: federal (usa) law restricts this device to sale by or on the order of a physician.Sterilized by ethylene oxide.Use by lot number do not use if package is damaged.Units single use do not resterilize catalog number caution, consult accompanying documents.Manufacturer length diameter max guidewire bard and fluoro-4 are trademarks and/or registered trademarks of c.R.Bard, inc.Authorized representative consult instructions for use.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical problems and applicable local, state, and federal laws and regulations.Contents: (1) ureteral stent (1) stent clamp (1) guidewire (1) push catheter bard® fluoro-4¿ silicone ureteral stent, bard® fluoro-4¿ silicone ureteral coil stent and bard® silicone ureteral coil stent with figure four end information for use device description: the bard® fluoro-4¿ silicone ureteral stent, the bard® fluoro-4¿ silicone ureteral coil stent and the bard® silicone ureteral coil stent with figure four end are silicone stents.The bard® fluoro-4¿ silicone ureteral stent and the bard® fluoro-4¿ silicone ureteral coil stent are highly radiopaque.The extra coils enable the stent device to accommodate most lengths of ureters.Each stent kit contains the following: 1 bard® stent 1 guidewire 1 push catheter 1 stent clamp 1 information for use indications for use: these stents are indicated to relieve obstruction in a variety of benign, malignant and post-traumatic conditions in the ureter such as stones and/or stone fragments, or other ureteral obstructions such as those associated with ureteral stricture, carcinoma of abdominal organs, retroperitoneal fibrosis or ureteral trauma, or in association with extracorporeal shock wave lithotripsy (eswl).The stent may be placed using endoscopic surgical techniques or percutaneously using standard radiographic technique.Warning: this is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Contraindications: there are no known contraindications to use.Precautions: 1.For single use only.Do not resterilize.Do not use if 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.3.Exercise care.Tearing of the stent can be caused by sharp instruments.4.Choice of stent size and duration of indwelling time are at the discretion of the physician.All stents may be subject to varying degrees of encrustation when placed in the urinary tract.Periodic checks of the stent by cystoscopic and/or radiographic means are recommended.When, at any time during the indwelling duration, encrustation is of sufficient severity that there is potential for occlusion of the stent or the patient experiences pain or discomfort which the physician determines to be associated with the presence of the stent, or if there is indication of infection in the area of the stent, the stent should be removed and, if the patient¿s condition permits, replaced with a new stent.5.Care should be exercised when removing the stent so as not to cause tearing or fragmentation.6.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.7.Multi-length ureteral stents: formation of knots in multi-length ureteral stents may occur.This may result in injury to the ureter during removal and/or the need for additional surgical intervention.The presence of a knot should be considered if significant resistance is encountered during attempts at removal.Directions for use: (open end) 1.Prior to removing guidewire from hoop, inject sterile water through port to activate lubricious coating.2.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.3.Pass the stent over the guidewire through the cystoscope, advancing it into the ureter with the push catheter under direct vision.Assistant holds the guidewire in position to prevent advancement of the wire into the renal parenchyma.4.Watch for the distal end of the stent at the ureterovesical junction.Stop advancement of the stent at that point.Assistant removes the guidewire as the operator holds the stent in position with the push catheter.The retention coil will form spontaneously.Carefully remove the push catheter from the cystoscope.Preloaded stent with clamp 1.Prior to removing guidewire from hoop, inject sterile water through port to activate lubricious coating.2.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 help keep stent in place for insertion.) 3.Place push catheter on guidewire until it abuts distal end of stent.4.Place small white clamp at most distal end of push catheter and clamp securely (see fig.1).This will ensure correct positioning of stent on the push catheter during insertion procedure.5.Insert stent.6.When placement is complete, release clamp by pushing top portion back and remove from push catheter (see fig.2).7.Hold push catheter and remove guidewire.The stent retention loop will form spontaneously.Then carefully remove push catheter from cystoscope.Note: 1.Final adjustment, if necessary, can be made with endoscopic forceps.Stents can be removed easily by gentle withdrawal traction using endoscopic forceps.2.Fluoroscopy facilitates stent placement; however, standard radiography may be used.3.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.©2016 c.R.Bard, inc.All rights reserved.Manufactured in mexico".

• Brand Name: BARD® FLUORO-4¿ SILICONE URETERAL STENT
• Type of Device: STENT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7862000
• MDR Text Key: 119815144
• Report Number: 1018233-2018-04081
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10801741011679
• UDI-Public: (01)10801741011679
• Combination Product (y/n): N
• PMA/PMN Number: K823487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

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 Model Number: 233624
• Device Catalogue Number: 233624
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/21/2018
• Initial Date FDA Received: 09/10/2018
• Supplement Dates Manufacturer Received: 09/22/2018
• Supplement Dates FDA Received: 10/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1