MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 INLAY OPTIMA URETERAL STENT WITHOUT GUIDEWIRE

Catalog Number 788626

Device Problems Break (1069); Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

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 string was defective.Before patient use, the stent broke in half when the string was being removed.There was no impact to the patient and only slight procedural delays.

Manufacturer Narrative

Received 1 used stent with the wire only.Visual inspection noted that the stent appeared to be broken into 2 pieces at the 26 cm marking.The broken section presented with a clean cut.The stent was received out of its individually sealed polybag.No pieces of the stent appeared to be missing.The following functional evaluation was performed: used a 0.038 guidewire; submerged the guidewire and stent in water to activate their coating; inserted the guidewire through the stent.During this test it was found that there was no difficulties when inserting the guidewire into the stent.A dimensional evaluation found that the stent was within specifications.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: "avoid improper handling of stent such as bending, kinking, tearing, etc.Misuse could damage the overall integrity of the stent; care should be exercised when removing the stent from the inner polybag to eliminate tearing or fragmentation." (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: INLAY OPTIMA URETERAL STENT WITHOUT GUIDEWIRE
• Type of Device: URETERAL 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: 5512753
• MDR Text Key: 40952931
• Report Number: 1018233-2016-00296
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2020
• Device Catalogue Number: 788626
• Device Lot Number: NGZK1105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2015
• 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