MAUDE Adverse Event Report: BOSTON SCIENTIFIC ZIPWIRE; WIRE, GUIDE, CATHETER

Model Number UPN M006630205B0

Device Problems Detachment Of Device Component (1104); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2015

Event Type  malfunction  

Event Description

During a right percutaneous nephrolithotomy ureteroscopy, and nephrostomy tube exchange with percutaneous access, the surgeon was using a zip wire and pulling it in and out of the ureter when he noticed the plastic coating was off.The surgeon was able to successfully retrieve the two plastic cover pieces with graspers from the cystoscopy tray.There was no harm to the patient.Manufacturer response for zip wire, zip wire (per site reporter): manufacturer was notified by or manager.

• Brand Name: ZIPWIRE
• Type of Device: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 5288504
• MDR Text Key: 33249952
• Report Number: 5288504
• Device Sequence Number: 1
• Product Code: EZB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/17/2015,12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/12/2017
• Device Model Number: UPN M006630205B0
• Device Lot Number: 10461507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/17/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 34 YR