MAUDE Adverse Event Report: COOK MEDICAL UNIVERSAL STENT-FIRM 6X26

Model Number G23406

Device Problems Break (1069); Difficult to Remove (1528); Unraveled Material (1664)

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

Event Date 08/20/2015

Event Type  malfunction  

Event Description

Universal stent-firm 6x26, while under fluoroscopy (no scope), the monofilament wire broke while within the patient.Wire had to be pulled and removed in four different pieces as it continued to unravel.Case time was increased by 10 minutes during this process of searching and removing the pieces from the patient.

• Brand Name: UNIVERSAL STENT-FIRM 6X26
• Type of Device: UNIVERSAL STENT-FIRM 6X26
• Manufacturer (Section D): COOK MEDICAL; bloomington IN 47402
• MDR Report Key: 5038573
• MDR Text Key: 24550780
• Report Number: MW5055802
• Device Sequence Number: 1
• Product Code: FEW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G23406
• Device Lot Number: 5942162
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR