MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD INLAY LUBRICIOUS COATED DOUBLE PIGTAIL URETERAL STENT

Catalog Number 777426

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 08/18/2014

Event Type  malfunction  

Event Description

It was reported that there were cracks in the middle of the tube, however, the stent had cracked, but was not broken.Per receipt of the sample it was found that the stent had broken.

Manufacturer Narrative

The sample was returned.For the reported issue the complaint is confirmed as cause unk after the visual inspection.The breakage site presents jagged edges and stress marks as indicative that the stent have been stressed beyond its tensile capabilities.The broken section is located at the middle.During the dimensional evaluation found all dimension within specification.Manufacturing a review was conducted and there was nothing found to indicate there was a manufacturing related cause for this event.The finished product met all specifications prior to being released for general distribution.The instructions for use states in the precautions" 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." (b)(4).

• Brand Name: INLAY LUBRICIOUS COATED DOUBLE PIGTAIL URETERAL STENT
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD; nogales, sonora ; MX
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD; km 7 carretera internacional; nogales, sonora ; MX
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4349326
• MDR Text Key: 5200853
• Report Number: 1018233-2014-00349
• 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: Foreign
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/07/2014

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: 07/31/2018
• Device Catalogue Number: 777426
• Device Lot Number: NGYB4395
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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