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

Catalog Number 787426

Device Problem Calcified (1077)

Patient Problem Injury (2348)

Event Date 03/20/2013

Event Type  Injury  

Event Description

It was reported that the patient was implanted with the device due to horseshoe kidney and kidney stones.Two months later, crystalization was found on the surface of the stent.The doctor conducted pneumatic lithotripsy to break down the stone and took out the stent.

Manufacturer Narrative

The complaint was confirmed as a use-related issue.During visual evaluation, some calcification was noted on the entire stent surface and more encrustation was observed on the pigtails.The surface of the stent was inspected under magnification for any condition or visible defects which could have caused or contributed to the reported event.No conditions were found that would point to a manufacturing related issue.During functional testing, the calcification was removed and the stent was submerged under water.Upon removal from the water, it was observed that the coating had been activated and was present along the length of the stent.A manufacturing 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.(b)(4).

• Brand Name: INLAY OPTIMA 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 8562 1; MX 85621
• Manufacturer Contact: kim shirah ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 3628680
• MDR Text Key: 3987415
• Report Number: 1018233-2014-00032
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K043193
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/07/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: 787426
• Device Lot Number: NGWG2433
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/14/2013
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/07/2013
• Initial Date FDA Received: 02/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2012
• 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
• Patient Outcome(s): Required Intervention