MAUDE Adverse Event Report: COOK INC UNIVERSA FIRM URETERAL STENT SET; FAD STENT, URETERAL

Model Number N/A

Device Problems Break (1069); Material Separation (1562); Stretched (1601)

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

Event Date 01/29/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

The reporter stated they received a generalized complaint from the physician who stated she was experiencing some issues while using the 6 french universa firm ureteral stent set with hydrophilic coating in different lengths.The physician stated that the tether on the stents was stretching and becoming too thin, it was curling and at times it would break or disconnect from the stents.It is not clear how many actual devices this happened to.There were no unintended sections of the device that remained inside of the patient¿s body, nor did the patient experience any adverse effects due to this occurrence.The customer indicated there would be no photos sent of the device, nor return of the device.No further information was provided.

Manufacturer Narrative

Investigation - evaluation.A review of documentation, manufacturing instructions, instructions for use (ifu), and quality control data was conducted during the investigation.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality; device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A lot number was not provided, therefore a review of non-conformances and complaint history search could not be completed.As no sample was returned and no lot numbers were provided a root cause cannot be determined for the reported event.We will notify the appropriate personnel and continue to monitor for similar complaints.As per the risk assessment no further action is required.

• Brand Name: UNIVERSA FIRM URETERAL STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6357151
• MDR Text Key: 68363229
• Report Number: 1820334-2017-00317
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961446
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UFH-626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2017
• 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