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

Catalog Number 788626

Device Problems Split (2537); Defective Device (2588)

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

Event Date 04/27/2015

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 broke at the end when trying to place the stent over the guidewire before it was inserted into the patient.The end of the stent was split lengthwise.The stent was to be used during a cystoscopy.Another stent was inserted to complete the procedure.The stent defect was noted after placement and was removed after the defect was noted.There was no known problems when placing the device.An olympus cystoscope was used during the procedure with an unknown guidewire.No guidewire was included with the stent.The stent was split lengthwise at the proximal-bladder end.The patient had hydronephrosis-right ureter and ureteral stones.The current status of the patient is unknown and no pieces were left within the patient.No patient injury was reported.

Manufacturer Narrative

The device was not returned for evaluation.The reported event could not be confirmed as there was no sample returned.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: " 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." 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.Device discarded.

• 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 caretera int'l; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 4798453
• MDR Text Key: 15367911
• Report Number: 1018233-2015-00161
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2015

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: 788626
• Device Lot Number: NGZC2622
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2015
• Initial Date FDA Received: 05/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1