MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 INLAY OPTIMA URETERAL STENT WITHOUT GUIDEWIRE, 6 FR. X 24CM

Catalog Number 788624

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2016

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 the end of the stent was broken.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the end of the stent was broken.

Manufacturer Narrative

Received 1 opened bard inlay optima ureteral stent.The reported event was confirmed; however, the cause is unknown.During the visual inspection it was noted that the first eyelet of bladder end was torn.The broken section presented a clean cut.The stent was received out of its individual sealed polybag.The dimensional evaluation results are as follows: dimensional evaluation: in order to verify the sample dimensions, it was measured per (b)(4) rev.1: (b)(4).The sample was found within specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "precautions: suture may be cut off prior to stent placement.Remove suture if indwelling time is expected to be longer than 14 days.Avoid improper handling of stent such as bending, kinking, tearing, etc.Misuse could damage the overall integrity of the stent.Ureteral stents should be checked periodically for signs of encrustation and proper function.Periodic checks of the stent by cystoscopic and/or radiographic procedures are recommended at intervals deemed to be appropriate by the physician in consideration of the individual patient¿s condition and other patient specific factors.When long-term use is indicated, it is recommended that indwelling time not exceed 365 days.The stent is not intended as a permanent indwelling device.* 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.Care should be exercised when removing the stent from the inner polybag to eliminate tearing or fragmentation.The insertion of a ureteral stent should only be done by those individuals who have comprehensive training in the techniques and risks of the procedure.Directions for use: determine the proper stent length for the patient.This is generally calculated from the baseline pyelogram.Accurate measurements will optimize drainage efficiency and patient comfort.Insert the cystoscope then pass the guidewire* through the scope until the tip is in the renal pelvis.Move the pigtail straightener over the proximal end (kidney coil end) of the ureteral stent allowing easier insertion onto the guidewire.Remove pigtail straightener once the stent is secure on the guidewire.Pass the stent over the guidewire through the cystoscope by using the push catheter for proper placement.Watch the distal end (bladder coil end) of the stent or the radiopaque, proximal end of the pusher.Stop advancing when the stent¿s distal end marker reaches the ureterovesical junction (uvj).**(see below for proper placement directions on the multi-length ureteral stent.) withdraw the guidewire slowly.The stent will form a pigtail automatically.Carefully remove the push catheter.*activate the guidewire coating according to the ¿instructions for use¿ found within the guidewire packaging.**multi-length ureteral stent placement: to accurately size this stent count the marker bands as it is being advanced into the ureter.The first large band indicates the 22 cm length.The second and third bands indicate 24 cm and 26 cm lengths respectively.The last large band is the 28 cm length.If you need to place for the 30 cm and 32 cm lengths, use the attached suture or endoscopic forceps to gently pull back on the stent unwinding the coil from the kidney.Warning: 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.This is a single use device.Do not re-sterilize 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." (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.

Event Description

It was reported that the end of the stent was allegedly broken.

• Brand Name: INLAY OPTIMA URETERAL STENT WITHOUT GUIDEWIRE, 6 FR. X 24CM
• Type of Device: 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: 6138726
• MDR Text Key: 61539838
• Report Number: 1018233-2016-01734
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2016

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 Expiration Date: 01/27/2021
• Device Catalogue Number: 788624
• Device Lot Number: NGAS2892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/16/2016; 01/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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