MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 FLUORO-4 SILICONE URETERAL COIL STENT

Catalog Number 277408

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/28/2015

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.

Event Description

It was reported that there was a defect at the tip of the device which prevented its use.Per receipt of the sample, the stent was broken.

Manufacturer Narrative

Received 1 used stent only.Visual inspection noted that one of the pigtails of the stent was broken near a perforation.The broken piece of the stent was not returned with the sample.A functional test was performed by inserting an in house guidewire (0.38¿that was activated with water for 2 minutes) into the stent.The guidewire was inserted without difficulty and no resistance was met during insertion.A dimensional evaluation found that the device was within specifications.A tactile evaluation was performed and no deficiencies were noted.The surface was found to be smooth with no manufacturing defects.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The complaint was confirmed with an unknown root cause.The instructions for use state the following: "precautions: 1.For single use only.Do not re-sterilize.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.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.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." (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.

• Brand Name: FLUORO-4 SILICONE URETERAL COIL STENT
• Type of Device: FLUORO-4 SILICONE URETERAL COIL 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: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5435628
• MDR Text Key: 38712056
• Report Number: 1018233-2016-00110
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K823487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2019
• Device Catalogue Number: 277408
• Device Lot Number: NGYI1106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2014
• 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