MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 INLAY OPTIMA URETERAL STENT; INLAY OPTIMA STENT

Catalog Number 788624

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2015

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 the inlay optima stent tip was frayed.The physician noticed the tip of the stent was frayed after it was placed in the patient.The stent was removed and replaced.No patient injury was reported.

Manufacturer Narrative

Received 1 used inlay optima ureteral stent with the original unit packaging.Visual inspection noted that one of the pigtails was broken.The broken piece was not returned with the sample.The broken section of the sample received showed signs of stress marks indicating that the stent was stretched beyond its tensile capabilities.The stent was received outside of its individual sealed polybag.A functional and dimensional evaluation was performed and the stent was found to be within specifications.A tactile evaluation was performed.There were no manufacturing deficiencies noted during the evaluation that would have contributed to the reported issue.There were no deformations on the returned stent.The reported issue was confirmed with an unknown root cause.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: "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
• Type of Device: INLAY OPTIMA 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: 5168798
• MDR Text Key: 29323501
• Report Number: 1018233-2015-00406
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2015

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: 12/29/2019
• Device Catalogue Number: 788624
• Device Lot Number: NGZD4321
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/28/2015
• Initial Date FDA Received: 10/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2015
• 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