MAUDE Adverse Event Report: COOK MEDICAL AMPLATZ; KIT, URETERAL STENT

Catalog Number UTSSW-8.5-26-AMP-RH

Device Problem Entrapment of Device (1212)

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

Event Date 02/11/2016

Event Type  malfunction  

Event Description

When opening the package, it was noted that the deployment string was tangled and the radiology tech was not able to untangle it.The interventional radiologist stated that this was the second time this has happened.The next package that was then opened was also tangled, but they were able to use it and the procedure was completed without complications.

• Brand Name: AMPLATZ
• Type of Device: KIT, URETERAL STENT
• Manufacturer (Section D): COOK MEDICAL; 750 daniels way; bloomington IN 47402
• MDR Report Key: 5633487
• MDR Text Key: 44461533
• Report Number: 5633487
• Device Sequence Number: 1
• Product Code: FAD
• 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: 03/07/2016

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: Physician
• Device Expiration Date: 11/15/2018
• Device Catalogue Number: UTSSW-8.5-26-AMP-RH
• Device Lot Number: 6383001
• Other Device ID Number: G09710
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2016
• Event Location: Other
• Date Report to Manufacturer: 03/07/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/05/2016
• 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: 63 YR
• Patient Weight: 60