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

Catalog Number 778626

Device Problems Fracture (1260); Out-Of-Box Failure (2311)

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

Event Date 08/05/2015

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 stent was fractured when the package was opened.

Manufacturer Narrative

Received one used inlay ureteral stent.Visual inspection noted that one of the pigtails had cracked.No pieces of the stent appear to be missing.Further visual evaluation found that kidney end is broken in eyelet.The broken section was still attached to the stent; also it presents stress marks; like the stent was stressed beyond its tensile capabilities.Functional evaluation found no difficulty in the stent when the guidewire slipped through it.The stent dimensions were found within specification.The reported event is confirmed with the cause unknown.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: "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.Exercise care.Tearing of the stent can be caused by sharp instruments.Care should be exercised when removing the stent from inner polybag so as not to cause tearing or fragmentation." 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 PIGTAIL URETERAL STENT
• 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: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5049715
• MDR Text Key: 25539651
• Report Number: 1018233-2015-00331
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K983498
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 09/30/2015

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: 07/31/2019
• Device Catalogue Number: 778626
• Device Lot Number: NGYJ3767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2014
• 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