MAUDE Adverse Event Report: COOK COOK MEDICAL; STENT

Model Number 6X24 SOFT STENT

Device Problems Break (1069); Material Frayed (1262)

Patient Problem No Code Available (3191)

Event Date 10/18/2016

Event Type  malfunction  

Event Description

Patient with a large obstructing right upj stone.When placing stent the string on the stent kept fraying and eventually broke all together inside the patient's bladder.Surgeon was able to retrieve the remaining string which added more time in surgery under anesthesia.

• Brand Name: COOK MEDICAL
• Type of Device: STENT
• Manufacturer (Section D): COOK; bloomington IN 47402
• MDR Report Key: 6046650
• MDR Text Key: 58244104
• Report Number: MW5065527
• Device Sequence Number: 1
• Product Code: FGE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/19/2016

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 Model Number: 6X24 SOFT STENT
• Device Lot Number: 5902330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 86